Evaluating 18F-MFBG PET Imaging for Pheochromocytoma

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

This study is testing a new imaging method called 18F-MFBG PET to see if it can help people with pheochromocytoma get better and faster pictures of their tumors compared to traditional methods.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (other)
• Locations: 2 sites (Hangzhou, Zhejiang and 1 other locations)
• Trial ID: NCT06813742 on ClinicalTrials.gov

What this trial studies

This study aims to assess the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients diagnosed with pheochromocytoma. It focuses on the advantages of 18F-MFBG over traditional imaging methods, particularly its ability to provide better image quality and quicker imaging times. Patients with suspected or confirmed pheochromocytoma will be enrolled, and the study will evaluate the safety profile and effectiveness of this imaging technique. The goal is to improve diagnostic accuracy and facilitate better clinical management of the condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 30-80 years with clinically diagnosed pheochromocytoma who can provide informed consent.

Not a fit: Patients with serious primary diseases, uncontrolled hypertension, or contraindications to PET imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic accuracy for pheochromocytoma, enabling better treatment planning for patients.

How similar studies have performed: Preliminary data suggest that 18F-MFBG imaging has shown promise, indicating potential success in this novel approach.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang and 1 other locations

• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
• The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Peipei Wang, MD

Conditions: Pheochromocytoma