18F-mFBG PET Imaging in the Evaluation of Pheochromocytoma

A Prospective Exploratory Study Evaluating the Diagnostic Usefulness of 18F-mFBG PET Imaging in Pheochromocytoma

The aim of this study is to evaluate the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with pheochromocytoma.

Study Overview

• Status: Recruiting
• Conditions: Pheochromocytoma
• Intervention / Treatment: Drug: 18F-MFBG

Detailed Description

Pheochromocytoma highly expresses norepinephrine transporter (NET) which is targeted by function alanalogue of norepinephrine, 123/131I-MlBG. However, low spatial resolution of 123/131I-MlBG and inaccurate attenuation correction of single photon emission tomography (SPECT/CT) will affect the image quality of MlBG SPECT and lead to poor diagnosis of small lesions. In addition, 123l-MlBG imaging is usually performed at 24h after injection, while 131I-MlBG is performed at 48h or even 72h after injection. The procedure is complicated and takes a long time, which limits clinical application. 18F-labeled MFBG is an ideal tracer to show the expression of NET. Preliminary data show that 18F-MFBG imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. Patients can undergo PET 0.5 hours after injection without special preparation. Our study will assess the safety profile, image quality and evaluate the diagnostic performance and tumor burden of 18F-MFBG. Patients with suspected or histologically confirmed pheochromocytoma will be enrolled in this study.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Peipei Wang, MD; Phone Number: 86 18511395988; Email: wpp199411@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University school of medicine
      • Contact: Xinhui Su, MD; Phone Number: 86 13806071262; Email: suxinhui@zju.edu.cn
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • The First Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Peipei Wang, MD; Phone Number: 86 18511395988; Email: wpp199411@163.com
      • Contact: Xinhui Su, MD; Phone Number: 86 13806071262; Email: suxinhui@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with suspected or confirmed pheochromocytoma

Description

Inclusion Criteria:

1. Aged 30-80 years old, primary school or above, with a regular caregiver;
2. Clinically diagnosed patients with pheochromocytoma;
3. Can provide informed consent, can understand and comply with the study requirements.

Exclusion Criteria:

1. Patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system;
2. Uncontrolled hypertension or high-risk BP (i.e., systolic BP > 180 mmHg or diastolic BP > 110 mmHg);
3. Patients with mental disorders or primary affective disorders;
4. Unable to understand and adhere to the study protocol or provide informed consent;
5. Contraindications to PET imaging (including pregnant women, lactating women, and women of childbearing age with recent childbearing plans, etc.);
6. Allergy to imaging agents;
7. Patients who were unable to cooperate with PET scanning, such as hypoglycemia, severe pain or tremor.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
18F-MFBG PET/CT in Pheochromocytoma; Each patient receive a single intravenous injection of 18F-MFBG 5.55 MBq/kg and undergo PET/CT or PET/MR scan after 60 min post-injection.	Drug: 18F-MFBG; Patients with pheochromocytoma malignancies receive 5.55 MBq/kg of 18F-MFBG intravenously followed by PET/CT or PET/MR after 60min of injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between positive and negative 18F-mFBG PET/CT or PET/MR Imaging and pathological diagnosis and treatment effect in patients with pheochromocytoma.	Main outcome measure	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
False positive and false negative results of 18F-mFBG PET/CT or PET/MR Imaging in patients with pheochromocytoma.	Secondary outcome measure	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 5, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 24, 2024
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Paraganglioma; Neuroendocrine Tumors; Pheochromocytoma
• Other Study ID Numbers: FAHZU-MFBG-PHEO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No