18F-mFBG PET Imaging in the Evaluation of Pheochromocytoma

NCT06813742 | Recruiting

• 1 other identifier: FAHZU-MFBG-PHEO
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pheochromocytoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• False positive and false negative results of 18F-mFBG PET/CT or PET/MR Imaging in patients with pheochromocytoma.

  through study completion, an average of 1 year

Study Arms (1)

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

Interventions

18F-MFBG DRUG

Patients with pheochromocytoma malignancies receive 5.55 MBq/kg of 18F-MFBG intravenously followed by PET/CT or PET/MR after 60min of injection.

18F-MFBG PET/CT in Pheochromocytoma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with suspected or confirmed pheochromocytoma

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (2)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Pheochromocytoma

Interventions

3-fluorobenzylguanidine

Condition Hierarchy (Ancestors)

Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Central Study Contacts

Peipei Wang, MD

CONTACT

86 18511395988; wpp199411@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: February 7, 2025
• Study Start: May 1, 2023
• Primary Completion: December 5, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2024-12

Locations

CN (2)