18F-mFBG PET Imaging in the Evaluation of Pheochromocytoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pheochromocytoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

18F-MFBG

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No