Clinical trial • Phase II • Neurology

RO7269162 for Prodromal Alzheimer's disease | Alzheimer's disease

Phase II trial of RO7269162 for Prodromal Alzheimer's disease | Alzheimer's disease.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Prodromal Alzheimer's disease | Alzheimer's disease
Trial Stage
Phase II
Drug Modality
Small molecule | Radiopharmaceutical

Key dates

Initial CTIS Submission Date
09-11-2023
First CTIS Authorization Date
11-03-2024

Trial design

Randomised, placebo ro7269162 — daily oral administration (placebo; dose not specified).-controlled Phase II trial in Spain, Denmark, Germany and others.

Randomised
Yes
Comparator
Placebo RO7269162 — daily oral administration (placebo; dose not specified).
Target Sample Size
202

Eligibility

Recruits 202 Vulnerable population selected: participants may be cognitively unimpaired or have MCI due to Alzheimer’s disease. A study partner is required (see inclusion criterion 5) who must have frequent contact with the participant, be willing and able to provide accurate information regarding the participant’s cognitive and functional abilities and sign the necessary ICF(s), and possess sufficient cognitive capacity to report accurately. Multiple dedicated ICF/SIS templates are provided (participant, study partner, caregiver, pregnant partner, infant authorization, home nursing) and country-specific participant information/ICFs are included in the submission..

Vulnerable Population
Vulnerable population selected: participants may be cognitively unimpaired or have MCI due to Alzheimer’s disease. A study partner is required (see inclusion criterion 5) who must have frequent contact with the participant, be willing and able to provide accurate information regarding the participant’s cognitive and functional abilities and sign the necessary ICF(s), and possess sufficient cognitive capacity to report accurately. Multiple dedicated ICF/SIS templates are provided (participant, study partner, caregiver, pregnant partner, infant authorization, home nursing) and country-specific participant information/ICFs are included in the submission.

Inclusion criteria

  • {"criterion_text":"- 1. Body Mass Index (BMI) between 18 to 35 kg/m2 inclusive, at screening"}
  • {"criterion_text":"- 2. Participants must be either cognitively unimpaired or with a diagnosis of MCI due to AD, according to the NIA – AA workgroups on diagnostic guidelines for AD, and/or according to the updated NIA-AA research framework"}
  • {"criterion_text":"- 3. Clinical Dementia Rating-Global Score (CDR-GS) of 0 or 0.5"}
  • {"criterion_text":"- 4. Positive amyloid PET scan based on a cut-off of ≥24 CL units"}
  • {"criterion_text":"- 5. Availability of a person (referred as a “study partner” throughout the protocol) who: (a) has frequent and sufficient contact (e.g., minimum twice a week in-person, via telephone, video calls, by e-mail or other electronic means) with the participant, and is willing and able to provide accurate information regarding the participant’s cognitive and functional abilities, signs the necessary ICF(s), and has sufficient cognitive capacity to accurately report on the participant’s cognitive and functional abilities; (b) is in sufficient good general health to have a high likelihood of maintaining the same level of interaction with the participant and participation in study procedures throughout the duration of the study; and (c) is fluent in the language of the tests used at the study site. Please note that the study partner does not need to be a family member. Every effort should be made to keep the same study partner throughout the study."}
  • {"criterion_text":"- 6. In case of treatment with symptomatic AD medications, dosing regimen must be stable for at least eight weeks prior to first IMP intake"}

Exclusion criteria

  • {"criterion_text":"- 1. Any medical history or evidence of a condition other than AD that may affect cognition"}
  • {"criterion_text":"- 2. History or presence of significant cardiovascular conditions and/or significant hematological disease"}
  • {"criterion_text":"- 3. History or presence of chronic kidney disease and/or impaired hepatic function"}
  • {"criterion_text":"- 4. Uncontrolled/poorly controlled diabetes"}
  • {"criterion_text":"- 5. History of or activate inflammatory bowel disease"}
  • {"criterion_text":"- 6. Have received any passive or active immunotherapy (immunoglobulin) or other long-acting biologic agent that is under evaluation or approved to prevent or postpone cognitive decline administered within 1 year prior to first IMP intake, and/or any other investigational treatment within five half-lives or 16 weeks prior to screening, whichever is longer."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Nature, incidence, severity, and outcome of AEs","definition_or_measurement_approach":"Adverse event reporting (nature, incidence, severity and outcome) captured per standard safety reporting procedures."}
  • {"endpoint_text":"- 2. Changes from baseline in vital signs, ECG parameters, Columbia-Suicide Severity Rating Scale (C-SSRS) and safety laboratory findings","definition_or_measurement_approach":"Change from baseline assessments for vital signs, ECG parameters, C-SSRS and clinical laboratory safety tests."}
  • {"endpoint_text":"- 3. Change from baseline in brain amyloid load, as measured by amyloid PET scan","definition_or_measurement_approach":"Quantitative change from baseline in brain amyloid load assessed by amyloid PET imaging (amyloid PET scan)."}

Secondary endpoints

  • {"endpoint_text":"- 1. Change from baseline in Aβ37, Aβ38, Aβ40 and Aβ42 in CSF and Aβ40 and Aβ42 in plasma","definition_or_measurement_approach":"Change from baseline in specified Aβ peptide concentrations measured in CSF and plasma using bioanalytical assays."}
  • {"endpoint_text":"- 2. Plasma concentrations of RO7269162 (and its metabolite[s] as appropriate)","definition_or_measurement_approach":"Plasma pharmacokinetic (PK) concentration measurements of RO7269162 and metabolites."}
  • {"endpoint_text":"- 3. CSF concentrations of RO7269162 (and its metabolite[s] as appropriate)","definition_or_measurement_approach":"CSF pharmacokinetic concentration measurements of RO7269162 and metabolites."}

Recruitment

Planned Sample Size
202
Recruitment Window Months
39
Consent Approach
Informed consent is required from the participant; a study partner is required and must sign the necessary ICF(s) and be able to provide accurate information on the participant. Multiple ICFs and subject information sheets are provided (participant, study partner, caregiver, pregnant partner, infant authorization, home nursing, optional prescreening and PK optional forms). Country-specific ICF materials are included in the submission (documents labeled for DE, PL, FR and country-specific participant information), indicating consent materials are prepared for local use.

Geography

Total Number Of Sites
47
Total Number Of Participants
202

Spain

Earliest CTIS Part Ii Submission Date
28-02-2024
Latest Decision Or Authorization Date
12-03-2024
Processing Time Days
13
Number Of Sites
12
Number Of Participants
48

Sites

Site Name
Hospital Universitari General De Catalunya
Department Name
Neurología
Principal Investigator Name
Ernest Balaguer Martínez
Principal Investigator Email
e.balaguer@udic.es
Contact Person Name
Ernest Balaguer Martínez
Contact Person Email
e.balaguer@udic.es
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Neurología
Principal Investigator Name
Lamberto Landete Pascual
Principal Investigator Email
landete.investigacion@gmail.com
Contact Person Name
Lamberto Landete Pascual
Site Name
Hospital Universitario Reina Sofia
Department Name
Neurología
Principal Investigator Name
Eduardo Agüera Morales
Principal Investigator Email
doctoredu@gmail.com
Contact Person Name
Eduardo Agüera Morales
Contact Person Email
doctoredu@gmail.com
Site Name
Hospital Victoria Eugenia De La Cruz Roja Espanola
Department Name
Neurología
Principal Investigator Name
Félix Viñuela Fernández
Principal Investigator Email
fvinuela@us.es
Contact Person Name
Félix Viñuela Fernández
Contact Person Email
fvinuela@us.es
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Neurología
Principal Investigator Name
Rafael Arroyo González
Principal Investigator Email
rafaelarroyo09@gmail.com
Contact Person Name
Rafael Arroyo González
Contact Person Email
rafaelarroyo09@gmail.com
Site Name
Policlinica Gipuzkoa S.A.
Department Name
Neurología
Principal Investigator Name
Gurutz Linazasoro Cristóbal
Principal Investigator Email
glinazasoro@telefonica.net
Contact Person Name
Gurutz Linazasoro Cristóbal
Contact Person Email
glinazasoro@telefonica.net
Site Name
Hospital Universitario De Salamanca
Department Name
Psiquiatría
Principal Investigator Name
Ángel Luis Montejo González
Principal Investigator Email
amontejo@usal.es
Contact Person Name
Ángel Luis Montejo González
Contact Person Email
amontejo@usal.es
Site Name
Fundacio Ace Institut Catala De Neurociencies Aplicades
Department Name
Neurología
Principal Investigator Name
Merce Boada Rovira
Principal Investigator Email
mboada@fundacioace.org
Contact Person Name
Merce Boada Rovira
Contact Person Email
mboada@fundacioace.org
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurología
Principal Investigator Name
Miquel Baquero Toledo
Principal Investigator Email
miquelbaquero@gmail.com
Contact Person Name
Miquel Baquero Toledo
Contact Person Email
miquelbaquero@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Neurología
Principal Investigator Name
Alberto Villarejo Galende
Principal Investigator Email
avgalende@yahoo.es
Contact Person Name
Alberto Villarejo Galende
Contact Person Email
avgalende@yahoo.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Neurología
Principal Investigator Name
Eloy Rodríguez Rodríguez
Principal Investigator Email
eloymrod@gmail.com
Contact Person Name
Eloy Rodríguez Rodríguez
Contact Person Email
eloymrod@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Neurología
Principal Investigator Name
Emilio Franco Macías
Principal Investigator Email
efranco17@gmail.com
Contact Person Name
Emilio Franco Macías
Contact Person Email
efranco17@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
11-03-2024
Processing Time Days
7
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Aarhus Universitetshospital
Department Name
Neurologisk Forskning
Principal Investigator Name
Hanne Gottrup
Principal Investigator Email
hagott@rm.dk
Contact Person Name
Hanne Gottrup
Contact Person Email
hagott@rm.dk
Site Name
Aalborg University Hospital
Department Name
Neurologisk Afdeling, Demensenheden
Principal Investigator Name
Karsten Vestergard
Principal Investigator Email
k.vestergaard@rn.dk
Contact Person Name
Karsten Vestergard
Contact Person Email
k.vestergaard@rn.dk
Site Name
Rigshospitalet
Department Name
Hukommelsesklinikken
Principal Investigator Name
Kristian Steen Frederiksen
Principal Investigator Email
kristian.steen.frederiksen@regionh.dk
Contact Person Name
Kristian Steen Frederiksen

Germany

Earliest CTIS Part Ii Submission Date
20-11-2023
Latest Decision Or Authorization Date
12-03-2024
Processing Time Days
113
Number Of Sites
9
Number Of Participants
40

Sites

Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Psychiatrie und Psychotherapie
Principal Investigator Name
Timo Grimmer
Principal Investigator Email
timo.grimmer@mri.tum.de
Contact Person Name
Timo Grimmer
Contact Person Email
timo.grimmer@mri.tum.de
Site Name
Zentralinstitut Fuer Seelische Gesundheit
Department Name
Zentralinstitut für Seelische Gesundheit
Principal Investigator Name
Lucrezia Hausner
Principal Investigator Email
lucrezia.hausner@zi-mannheim.de
Contact Person Name
Lucrezia Hausner
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
ECRC
Principal Investigator Name
Oliver Peters
Principal Investigator Email
oliver.peters@charite.de
Contact Person Name
Oliver Peters
Contact Person Email
oliver.peters@charite.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Neurologie
Principal Investigator Name
Dorothee Saur
Principal Investigator Email
dorothee.saur@medizin.uni-leipzig.de
Contact Person Name
Dorothee Saur
Site Name
Klinikum Frankfurt (Oder) GmbH
Department Name
Klinik für Psychiatrie und Psychotherapie
Principal Investigator Name
Oliver Peters
Principal Investigator Email
Oliver.Peters@klinikumffo.de
Contact Person Name
Oliver Peters
Contact Person Email
Oliver.Peters@klinikumffo.de
Site Name
Charite Universitaetsmedizin Berlin KöR (Lichterfelde campus)
Department Name
Campus Benjamin Franklin - Neurologie-
Principal Investigator Name
Andreas Lüschow
Principal Investigator Email
andreas.lueschow@charite.de
Contact Person Name
Andreas Lüschow
Contact Person Email
andreas.lueschow@charite.de
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Klinik für Neurologie
Principal Investigator Name
Thomas Duning
Principal Investigator Email
thomas.duning@gesundheitnord.de
Contact Person Name
Thomas Duning
Site Name
Studienzentrum Dr. Bischof GmbH
Department Name
Studienzentrum Neurologie
Principal Investigator Name
Felix Bischof
Principal Investigator Email
felix.bischof@me.com
Contact Person Name
Felix Bischof
Contact Person Email
felix.bischof@me.com
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Klinik und Poliklinik für Neurologie
Principal Investigator Name
Matthias Pawlowski
Principal Investigator Email
matthias.pawlowski@ukmuenster.de
Contact Person Name
Matthias Pawlowski

Poland

Earliest CTIS Part Ii Submission Date
20-11-2023
Latest Decision Or Authorization Date
15-03-2024
Processing Time Days
116
Number Of Sites
9
Number Of Participants
70

Sites

Site Name
Podlaskie Centrum Psychogeriatrii
Principal Investigator Name
Jacek Dobryniewski
Principal Investigator Email
biuro@psychiatria.bialystok.pl
Contact Person Name
Jacek Dobryniewski
Contact Person Email
biuro@psychiatria.bialystok.pl
Site Name
Centrum Medyczne Senior
Department Name
Senior Sp. z o.o. Poradnia Psychogeriatryczna
Principal Investigator Name
Dorota Ussorowska
Principal Investigator Email
katarzyna.sobus@cmsenior.pl
Contact Person Name
Dorota Ussorowska
Contact Person Email
katarzyna.sobus@cmsenior.pl
Site Name
Etg Neuroscience Sp. z o.o.
Principal Investigator Name
Aleksandra Karbowniczek
Principal Investigator Email
neuroscience@etg-network.com
Contact Person Name
Aleksandra Karbowniczek
Contact Person Email
neuroscience@etg-network.com
Site Name
Euromedis Sp. z o.o.
Principal Investigator Name
Marcin Ratajczak
Principal Investigator Email
rejestracjabk@euromedis.pl
Contact Person Name
Marcin Ratajczak
Contact Person Email
rejestracjabk@euromedis.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Neurologii
Principal Investigator Name
Agnieszka Słowik
Principal Investigator Email
pwrona@su.krakow.pl
Contact Person Name
Agnieszka Słowik
Contact Person Email
pwrona@su.krakow.pl
Site Name
ProNeuro Centrum Medyczne
Principal Investigator Name
Ewa Krzystanek
Principal Investigator Email
biuro@proneuro.pl
Contact Person Name
Ewa Krzystanek
Contact Person Email
biuro@proneuro.pl
Site Name
Vitamed Galaj I Cichomski Sp. j.
Department Name
NZOZ Vitamed
Principal Investigator Name
Paweł Lisewski
Principal Investigator Email
kontakt@vitamed.info
Contact Person Name
Paweł Lisewski
Contact Person Email
kontakt@vitamed.info
Site Name
NZOZ Wroclawskie Centrum Alzheimerowskie
Principal Investigator Name
Marzena Zboch
Principal Investigator Email
kontakt@alzheimer.wroclaw.pl
Contact Person Name
Marzena Zboch
Contact Person Email
kontakt@alzheimer.wroclaw.pl
Site Name
Neuro-Care Sp. z o.o. sp.k.
Principal Investigator Name
Gabriela Kłodowska
Principal Investigator Email
neuro-care@neuro-care.pl
Contact Person Name
Gabriela Kłodowska
Contact Person Email
neuro-care@neuro-care.pl

Italy

Earliest CTIS Part Ii Submission Date
13-02-2024
Latest Decision Or Authorization Date
13-03-2024
Processing Time Days
29
Number Of Sites
6
Number Of Participants
24

Sites

Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
U.O. Malattie Neurodegenerative
Principal Investigator Name
Daniele Urso
Principal Investigator Email
d.urso@piafondazionepanico.it
Contact Person Name
Daniele Urso
Contact Person Email
d.urso@piafondazionepanico.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
U.O. Neurologia
Principal Investigator Name
Massimo Filippi
Principal Investigator Email
filippi.massimo@hsr.it
Contact Person Name
Massimo Filippi
Contact Person Email
filippi.massimo@hsr.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Dipartimento di Neuroscienze Umane
Principal Investigator Name
Giuseppe Bruno
Principal Investigator Email
giuseppe.bruno@uniroma1.it
Contact Person Name
Giuseppe Bruno
Contact Person Email
giuseppe.bruno@uniroma1.it
Site Name
Neurological Institute Foundation Casimiro Mondino
Department Name
U.O.C. Neurologia del Comportamento e CDCD
Principal Investigator Name
Alfredo Arturo Costa
Principal Investigator Email
alfredo.costa@mondino.it
Contact Person Name
Alfredo Arturo Costa
Contact Person Email
alfredo.costa@mondino.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Centro Disturbi della Memoria
Principal Investigator Name
Lucilla Parnetti
Principal Investigator Email
lucilla.parnetti@unipg.it
Contact Person Name
Lucilla Parnetti
Contact Person Email
lucilla.parnetti@unipg.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O.C. Neurologia
Principal Investigator Name
Alessandro Padovani
Principal Investigator Email
alessandro.padovani@unibs.it
Contact Person Name
Alessandro Padovani
Contact Person Email
alessandro.padovani@unibs.it

France

Earliest CTIS Part Ii Submission Date
23-02-2024
Latest Decision Or Authorization Date
18-03-2024
Processing Time Days
24
Number Of Sites
8
Number Of Participants
6

Sites

Site Name
Hospices Civils De Lyon
Department Name
Hôpital Neurologique Wertheimer
Principal Investigator Name
Hélène Mollion
Principal Investigator Email
helene.mollion@chu-lyon.fr
Contact Person Name
Hélène Mollion
Contact Person Email
helene.mollion@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Hôpital Charles Nicolle - Service de neurologie
Principal Investigator Name
David Wallon
Principal Investigator Email
david.wallon@chu-rouen.fr
Contact Person Name
David Wallon
Contact Person Email
david.wallon@chu-rouen.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hôpital La Grave - Centre de Recherche Clinique du Gérontopôle
Principal Investigator Name
Pierre-Jean Ousset
Principal Investigator Email
ousset.pj@chu-toulouse.fr
Contact Person Name
Pierre-Jean Ousset
Contact Person Email
ousset.pj@chu-toulouse.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Hôpital La Timone - Neurologie et neuropsychologie adultes
Principal Investigator Name
Mathieu Ceccaldi
Principal Investigator Email
mathieu.CECCALDI@ap-hm.fr
Contact Person Name
Mathieu Ceccaldi
Contact Person Email
mathieu.CECCALDI@ap-hm.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital Lariboisiere - Fernand Widal - Centre Neurologie Cognitive/CMRR
Principal Investigator Name
Claire Paquet
Principal Investigator Email
claire.paquet@aphp.fr
Contact Person Name
Claire Paquet
Contact Person Email
claire.paquet@aphp.fr
Site Name
Les Hopitaux Universitaires de Strasbourg
Department Name
Hôpital de la Robertsau - HDJ de recherche
Principal Investigator Name
Frédéric Blanc
Principal Investigator Email
frederic.blanc@chru-strasbourg.fr
Contact Person Name
Frédéric Blanc
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
CHU Lille - Hôpital Roger Salengro - Centre Mémoire de Ressources et de Recherche
Principal Investigator Name
Marie-Anne Mackowiak
Principal Investigator Email
marieanne.mackowiak@chu-lille.fr
Contact Person Name
Marie-Anne Mackowiak
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
CHU Nantes - CMRR Hôpital Laennec
Principal Investigator Name
Claire Boutoleau-Bretonnière
Principal Investigator Email
claire.boutoleaubretonniere@chu-nantes.fr
Contact Person Name
Claire Boutoleau-Bretonnière

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
sponsorDuties code 4 (as listed in submission)
Name
ICON Bioanalytical Laboratories
Responsibilities
sponsorDuties code 4 (as listed in submission)
Name
Labcorp Central Laboratory Services S.a.r.l.
Responsibilities
sponsorDuties code 4 (as listed in submission)
Name
Labcorp Early Development Laboratories Inc.
Responsibilities
sponsorDuties code 4 (as listed in submission)

Third parties

  • {"country":"United States","full_name":"Clario","duties_or_roles":"Cardiac safety, Imaging","organisation_type":"Health care"}
  • {"country":"Belgium","full_name":"S-Clinica","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"ICON Bioanalytical Laboratories","duties_or_roles":"4","organisation_type":"Health care"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Other third party duties","organisation_type":"Pharmaceutical company"}
  • {"country":"Australia","full_name":"Cogstate Limited","duties_or_roles":"Central scoring vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Home Nursing","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
RO7269162
Active Substance
RO7269162
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus 1
Frequency
Once daily
Investigational Product Name
Placebo RO7269162
Modality
Other
Frequency
Daily (placebo) as per study schedule
Investigational Product Name
FLUTEMETAMOL (18F)
Active Substance
FLUTEMETAMOL (18F)
Modality
Radiopharmaceutical
Routes Of Administration
INTRAVENOUS SLOW BOLUS INJECTION
Route
INTRAVENOUS SLOW BOLUS INJECTION
Authorisation Status
prodAuthStatus 2
Maximum Dose
185 MBq (max daily); total max 555 MBq
Investigational Product Name
FLORBETABEN (18F)
Active Substance
FLORBETABEN (18F)
Modality
Radiopharmaceutical
Routes Of Administration
INTRAVENOUS SLOW BOLUS INJECTION
Route
INTRAVENOUS SLOW BOLUS INJECTION
Authorisation Status
prodAuthStatus 2
Maximum Dose
300 MBq (max daily); total max 900 MBq

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