Clinical trial • Phase IV • Oncology

M-(18F)-FLUOROBENZYLGUANIDINE for Pheochromocytoma

Phase IV trial of M-(18F)-FLUOROBENZYLGUANIDINE for Pheochromocytoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Pheochromocytoma
Trial Stage
Phase IV
Drug Modality
Radiopharmaceutical
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
15-07-2024
First CTIS Authorization Date
05-08-2024

Trial design

Protocollary conventional CT imaging performed prior to surgery (comparator to [18F]mFBG PET-CT for lesion detection).-controlled Phase IV trial across 1 site in Netherlands.

Comparator
Protocollary conventional CT imaging performed prior to surgery (comparator to [18F]mFBG PET-CT for lesion detection).
Target Sample Size
10

Eligibility

Recruits 10 Vulnerable population not selected. Mentally or legally incapacitated patients are explicitly excluded. Written informed consent from the patient is required prior to participation; no provisions for assent or proxy consent are described..

Pregnancy Exclusion
Patient is pregnant or lactating.
Vulnerable Population
Vulnerable population not selected. Mentally or legally incapacitated patients are explicitly excluded. Written informed consent from the patient is required prior to participation; no provisions for assent or proxy consent are described.

Inclusion criteria

  • {"criterion_text":"- The patient has provided written informed consent authorization before participating in the study.\n- The patient is ≥18 years of age at the time of consent.\n- The patient has a diagnosis of pheochromocytoma with a known anatomical location or laboratory findings suspicious for pheochromocytoma defined as elevated serum/plasma metanefrines.\n- The patient should have surgery planned.\n- The patient should have had a CT scan not older than 8 weeks at time of the [18F]mFBG PET-CT..\n- The patient has an ECOG status of Grade 0 – 2."}

Exclusion criteria

  • {"criterion_text":"- Patient is mentally or legally incapacitated.\n- Patient is pregnant or lactating.\n- Patient has active serious infections not controlled by antibiotics.\n- Patient is unable or unwilling to undergo PET-CT scanning or surgery.\n- Patient did receive interfering treatment between conventional CT scanning and [18F]mFBG PET-CT."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The number of detected pheochromocytoma lesions, proved by histology, with pathological [18F]mFBG uptake, defined as focal uptake above surrounding normal tissue, compared to number of lesions detected on protocollary conventional CT imaging prior to surgery.","definition_or_measurement_approach":"Number of lesions proven by histology with pathological [18F]mFBG uptake (defined as focal uptake above surrounding normal tissue) compared to number of lesions detected on protocollary conventional CT imaging prior to surgery."}

Secondary endpoints

  • {"endpoint_text":"- 1)Optimal time point of [18F]mFBG PET-CT imaging via comparison of SUV values at 1 and 2 hours on PET-CT imaging.","definition_or_measurement_approach":"Comparison of SUV values at 1 hour vs 2 hours to determine optimal imaging time point."}
  • {"endpoint_text":"- 2)\tCorrelation of [18F]mFBG PET findings with pathology and immunohistochemistry analysis of norepinephrine transporter.","definition_or_measurement_approach":"Correlation between PET findings and pathology/immunohistochemistry results for norepinephrine transporter."}
  • {"endpoint_text":"- 3)\tEstimation of radiation dose of [18F]mFBG in normal tissues using dynamic PATLAK imaging","definition_or_measurement_approach":"Estimation of absorbed radiation dose in normal tissues using dynamic PATLAK imaging."}
  • {"endpoint_text":"- 4)\tSafety analysis of [18F]mFBG administration on clinical symptoms will be evaluated by Adverse Events outcomes","definition_or_measurement_approach":"Safety evaluated via recording and analysis of Adverse Events following [18F]mFBG administration."}

Recruitment

Planned Sample Size
10
Recruitment Window Months
63
Consent Approach
Written informed consent is required from the patient prior to participation. Only adults (≥18 years) are eligible; mentally or legally incapacitated patients are excluded. Subject information and informed consent form documents for adults are listed in the trial documents. Languages available are not specified.

Geography

Total Number Of Sites
1
Total Number Of Participants
10

Netherlands

Earliest CTIS Part Ii Submission Date
05-08-2024
Latest Decision Or Authorization Date
05-08-2024
Processing Time Days
0
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
Imaging and Oncology
Principal Investigator Name
Bart de Keizer
Principal Investigator Email
b.dekeizer@umcutrecht.nl
Contact Person Name
Bart de Keizer
Contact Person Email
b.dekeizer@umcutrecht.nl
Number Of Participants
10

Sponsor

Primary sponsor

Full Name
Universitair Medisch Centrum Utrecht
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
1-(3-(fluoro-18F)benzyl)guanidine ([18F]mFBG)
Active Substance
M-(18F)-FLUOROBENZYLGUANIDINE
Modality
Radiopharmaceutical
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Orphan Designation
Yes
Maximum Dose
2 MBq/kg

Related trials

Other published trials that may interest you.