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NCT Number: NCT06813742

18F-mFBG PET Imaging in the Evaluation of 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

    Time frame: through study completion, an average of 1 year

    Main outcome measure

Secondary outcomes

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

    Time frame: through study completion, an average of 1 year

    Secondary outcome measure

Study contacts

Contact information is provided by the study sponsor or research team.

Peipei Wang, MD

CONTACT

[email protected]

86 18511395988

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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