Clinical trial • Not applicable • Oncology|Other
FLUDEOXYGLUCOSE (18F) for Metastatic breast cancer
Not applicable trial of FLUDEOXYGLUCOSE (18F) for Metastatic breast cancer.
Overview
- Trial Therapeutic Area
- Oncology|Other
- Trial Disease
- Metastatic breast cancer
- Trial Stage
- Not applicable
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 04-07-2024
- First CTIS Authorization Date
- 14-10-2024
Trial design
Randomised, comparator arms: fdg-pet/ct based response monitoring versus conventional ct based response monitoring; no drug comparator specified.-controlled Not applicable trial across 11 sites in Denmark, Germany, Italy.
- Randomised
- Yes
- Comparator
- Comparator arms: FDG-PET/CT based response monitoring versus conventional CT based response monitoring; no drug comparator specified.
- Target Sample Size
- 420
Eligibility
Recruits 420 Vulnerable population not selected; Signed informed consent required. Participants must be able to read and understand the following languages based on their country of participation: in Denmark, patients must be able to read and understand Danish; in Italy, they must be able to read and understand Italian or English; and in Germany, they must be able to read and understand German or English..
- Pregnancy Exclusion
- Pregnant or lactating women
- Vulnerable Population
- Vulnerable population not selected; Signed informed consent required. Participants must be able to read and understand the following languages based on their country of participation: in Denmark, patients must be able to read and understand Danish; in Italy, they must be able to read and understand Italian or English; and in Germany, they must be able to read and understand German or English.
Inclusion criteria
- {"criterion_text":"- Women and men aged≥18 years\n- Diagnosis of distant relapsed MBC (biopsy-verified) or de novo breast cancer. In patients with distant relapsed MBC, biopsy verification from a distant metastasis is required. In patients with de novo MBC, biopsy verification of primary tumor and diagnostic imaging with distant metastasis with a typical pattern of MBC is required.\n- Considered eligible for first-line systemic treatment\n- Considered eligible for continuous treatment monitoring by scans\n- Signed informed consent\n- Participants must have the ability to read and understand the following languages based on their country of participation: in Denmark, patients must be able to read and understand Danish; in Italy, they must be able to read and understand Italian or English; and in Germany, they must be able to read and understand German or English."}
Exclusion criteria
- {"criterion_text":"- Pregnant or lactating women\n- Ongoing oncological treatment for another cancer\n- Exclusively brain metastasis\n- Allergy to FDG"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Quality of life","definition_or_measurement_approach":"Measured using patient-facing EQ-5D-5L and FACT-B questionnaires (documents listed in trial documents)"}
- {"endpoint_text":"- Time and exposure to oncologic treatment","definition_or_measurement_approach":""}
- {"endpoint_text":"- Cost-effectiveness","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 420
- Recruitment Window Months
- 63
- Consent Approach
- Signed informed consent required from participants; no minors included. Participant information and informed consent forms available in country-specific languages (Danish for Denmark; Italian or English for Italy; German or English for Germany) and English. Multiple subject information and informed consent form documents listed per country in trial documents.
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 420
Denmark
- Earliest CTIS Part Ii Submission Date
- 16-09-2024
- Latest Decision Or Authorization Date
- 14-10-2024
- Processing Time Days
- 28
- Number Of Sites
- 8
- Number Of Participants
- 240
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Oncology
- Principal Investigator Name
- Marie Benzon Mogensen
- Principal Investigator Email
- Marie.Benzon.Mogensen@regionh.dk
- Contact Person Name
- Marie Benzon Mogensen
- Contact Person Email
- Marie.Benzon.Mogensen@regionh.dk
- Site Name
- Aarhus Universitet
- Department Name
- Department of Nuclear Medicine
- Principal Investigator Name
- Mikkel Holm Vendelbo
- Principal Investigator Email
- mikven@rm.dk
- Contact Person Name
- Mikkel Holm Vendelbo
- Contact Person Email
- mikven@rm.dk
- Site Name
- Sygehus Soenderjylland Soenderborg
- Department Name
- Department of Oncology
- Principal Investigator Name
- Erik Hugger Jakobsen
- Principal Investigator Email
- Erik.Hugger.Jakobsen@rsyd.dk
- Contact Person Name
- Erik Hugger Jakobsen
- Contact Person Email
- Erik.Hugger.Jakobsen@rsyd.dk
- Site Name
- Copenhagen University Hospital
- Department Name
- Department of Oncology
- Principal Investigator Name
- Iben Kumler
- Principal Investigator Email
- Iben.Kumler@regionh.dk
- Contact Person Name
- Iben Kumler
- Contact Person Email
- Iben.Kumler@regionh.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Department of Nuclear Medicine
- Principal Investigator Name
- Helle Zacho
- Principal Investigator Email
- h.zacho@rn.dk
- Contact Person Name
- Helle Zacho
- Contact Person Email
- h.zacho@rn.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of Nuclear Medicine
- Principal Investigator Name
- Malene Grubbe Hildebrandt
- Principal Investigator Email
- Malene.Grubbe.Hildebrandt@rsyd.dk
- Contact Person Name
- Malene Grubbe Hildebrandt
- Contact Person Email
- Malene.Grubbe.Hildebrandt@rsyd.dk
- Site Name
- Lillebaelt Hospital
- Department Name
- Department of Nuclear Medicine
- Principal Investigator Name
- Paw Christian Holdgaard
- Principal Investigator Email
- Paw.Holdgaard@rsyd.dk
- Contact Person Name
- Paw Christian Holdgaard
- Contact Person Email
- Paw.Holdgaard@rsyd.dk
- Site Name
- Esbjerg Og Grindsted Sygehus
- Department Name
- Department of Nuclear Medicine
- Principal Investigator Name
- Mie Holm Vilstrup
- Principal Investigator Email
- Mie.Holm.Vilstrup@rsyd.dk
- Contact Person Name
- Mie Holm Vilstrup
- Contact Person Email
- Mie.Holm.Vilstrup@rsyd.dk
Germany
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 14-10-2024
- Processing Time Days
- 24
- Number Of Sites
- 1
- Number Of Participants
- 60
Sites
- Site Name
- Technical University Of Munich School Of Medicine
- Department Name
- Department of Nuclear Medicine
- Principal Investigator Name
- Wolfgang Weber
- Principal Investigator Email
- w.weber@tum.de
- Contact Person Name
- Wolfgang Weber
- Contact Person Email
- w.weber@tum.de
Italy
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 16-10-2024
- Processing Time Days
- 2
- Number Of Sites
- 2
- Number Of Participants
- 120
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Medical Oncology and Haematology
- Principal Investigator Name
- Claudio Zamagni
- Principal Investigator Email
- claudio.zamagni@aosp.bo.it
- Contact Person Name
- Claudio Zamagni
- Contact Person Email
- claudio.zamagni@aosp.bo.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Department of Biomedicine
- Principal Investigator Name
- Laura Evangelista
- Principal Investigator Email
- laura.evangelista@hunimed.eu
- Contact Person Name
- Laura Evangelista
- Contact Person Email
- laura.evangelista@hunimed.eu
Sponsor
Primary sponsor
- Full Name
- Odense University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Switzerland","full_name":"University Of Basel","duties_or_roles":"codes: 10,11; contact: werner.vach@unibas.ch","organisation_type":"Educational Institution"}
- {"country":"Denmark","full_name":"University of Southern Denmark","duties_or_roles":"codes: 6; contact: moolesen@health.sdu.dk","organisation_type":"Educational Institution"}
- {"country":"Sweden","full_name":"Lunds Universitet","duties_or_roles":"codes: 15 (Artificial intelligence-based image analysis), 3; contact: elin.tragardh@med.lu.se","organisation_type":"Educational Institution"}
- {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"codes: 1,7,8; contact: open@rsyd.dk","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- FLUDEOXYGLUCOSE (18F)
- Active Substance
- FLUDEOXYGLUCOSE (18F)
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- INTRAVENOUS
- Authorisation Status
- No marketing authorisation (marketingAuthNumber: -)
- Maximum Dose
- 400 MBq
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