mFBG PET-CT scan for the imaging of pheochromocytoma

Phase 1

Conditions: Pheochromocytoma – endocrine adrenal tumor
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-513622-35-00

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the number of detected pheochromocytoma lesions, proved by histology, with [18F]mFBG PET-CT compared to the conventional CT.;Secondary Objective: - To determine the optimal time point of [18F]mFBG PET-CT imaging via comparison of SUV values 1 and 2 hours on PET-CT imaging. - To correlate [18F]mFBG PET findings with pathology and immunohistochemistry analysis of norepinephrine transporter. - To estimate radiation dose of [18F]mFBG in normal tissues using dynamic PATLAK imaging. - To perform a safety analysis of [18F]mFBG administration on clinical symptoms by Adverse Events outcomes.;Primary end point(s): 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.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):1)Optimal time point of [18F]mFBG PET-CT imaging via comparison of SUV values at 1 and 2 hours on PET-CT imaging. 2)Correlation of [18F]mFBG PET findings with pathology and immunohistochemistry analysis of norepinephrine transporter. 3)Estimation of radiation dose of [18F]mFBG in normal tissues using dynamic PATLAK imaging 4)Safety analysis of [18F]mFBG administration on clinical symptoms will be evaluated by Adverse Events outcomes