Menu
Recruiting NCT06813742

18F-mFBG PET Imaging in the Evaluation of Pheochromocytoma

— Observational Pheochromocytoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 18F-MFBG.
Who it may be relevant to
Registry conditions: Pheochromocytoma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
  • The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT06813742 · FAHZU-MFBG-PHEO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗