Investigating a new imaging technique for pheochromocytoma (adrenal tumor)

Phase 1

• Conditions: Pheochromocytoma; MedDRA version: 20.1Level: LLTClassification code 10034876Term: PheochromocytomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005157-24-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-23
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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 patients should have had a CT scan at time of inclusion.
- The patient has an ECOG status of Grade 0 – 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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
Timepoint(s) of evaluation of this end point: Post acquisition of [18F]mFBG PET-CT imaging.;Main Objective: The primary objective of this study is to compare [18F]mFBG PET-CT imaging to conventional CT imaging performed in pheochromocytoma patients. ;Primary end point(s): The number of detected pheochromocytoma lesions with pathological [18F]mFBG uptake, defined as focal uptake above surrounding normal tissue compared to number of lesions detected on protocollary conventional CT imaging.;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. <br>- To correlate [18F]mFBG PET findings with pathology and immunohistochemistry analysis of norepinephrine transporter. <br>- To estimate radiation dose of [18F]mFBG in normal tissues using dynamic PATLAK imaging.<br>- To perform a safety analysis of [18F]mFBG administration on clinical symptoms by Adverse Events outcomes.<br>

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. <br>2) Correlation of [18F]mFBG PET findings with pathology and immunohistochemistry analysis of norepinephrine transporter. <br>3) Estimation of radiation dose of [18F]mFBG in normal tissues using dynamic PATLAK imaging<br>4) Safety analysis of [18F]mFBG administration on clinical symptoms will be evaluated by Adverse Events outcomes<br>;Timepoint(s) of evaluation of this end point: 1) Post acquisition of [18F]mFBG PET-CT;<br>2) Post surgery;<br>3) Post acquisition of [18F]mFBG PET-CT;<br>4) Up to 72 hours post injection.