Actively Recruiting

Age: 18Years - 80Years
All Genders
ID06813742

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

Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-08-07

80

Participants Needed

2

Research Sites

51 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate how well 18F-metafluorobenzylguanidine (18F-MFBG) PET imaging detects and measures tumor burden in patients with pheochromocytoma, a type of tumor that highly expresses the norepinephrine transporter (NET). The study addresses limitations of current imaging methods, such as low resolution and long procedure times, by assessing a newer tracer that may provide better image quality and faster results. Patients with suspected or confirmed pheochromocytoma will receive a single intravenous injection of 18F-MFBG at a dose of 5.55 MBq/kg. After 60 minutes, participants will undergo a PET/CT or PET/MR scan to visualize the tumors. This imaging method allows for scanning shortly after injection without special preparation, potentially improving diagnostic processes. During the study, researchers will evaluate the safety of 18F-MFBG, the quality of the images, and how accurately the scans correspond to pathological diagnosis and treatment effects. They will monitor false positive and false negative results over about one year. Participants will be assessed through imaging and clinical follow-up, contributing to understanding the tracer's diagnostic value in pheochromocytoma.

CONDITIONS

Brief Title

18F-mFBG PET Imaging in the Evaluation of Pheochromocytoma

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 30 to 80 years old, with at least primary school education and a regular caregiver
  • Clinically diagnosed with pheochromocytoma
  • Able to provide informed consent and comply with study requirements
Not Eligible

You will not qualify if you...

  • Serious diseases affecting heart, brain, liver, kidney, or blood system
  • Uncontrolled high blood pressure (systolic > 180 mmHg or diastolic > 110 mmHg)
  • Mental or primary affective disorders
  • Unable to understand or follow the study protocol or provide consent
  • Contraindications to PET imaging, including pregnancy, breastfeeding, or plans for pregnancy
  • Allergy to imaging agents
  • Inability to cooperate with PET scanning due to conditions like hypoglycemia, severe pain, or tremors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single day procedure

Participants receive a single intravenous injection of 18F-MFBG followed by PET/CT or PET/MR scanning to evaluate pheochromocytoma.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored for up to 1 year to assess diagnostic performance and treatment outcomes.

Visits as needed during follow-up

Trial Site Locations

Total: 2 locations

1

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

2

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

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Research Team

P

Peipei Wang, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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