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Clinical Trial NCT06813742 for Pheochromocytoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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18F-mFBG PET Imaging in the Evaluation of Pheochromocytoma 80
Clinical Trial NCT06813742 is an observational study for Pheochromocytoma that is recruiting. It started on 1 May 2023 with plans to enroll 80 participants. Led by First Affiliated Hospital of Zhejiang University, it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 7 August 2025.
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.
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...Show More
Official Title
A Prospective Exploratory Study Evaluating the Diagnostic Usefulness of 18F-mFBG PET Imaging in Pheochromocytoma
Conditions
PheochromocytomaOther Study IDs
- FAHZU-MFBG-PHEO
NCT ID Number
Start Date (Actual)
2023-05-01
Last Update Posted
2025-08-07
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
80
Study Type
Observational
Status
Recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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 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
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
False positive and false negative results of 18F-mFBG PET/CT or PET/MR Imaging in patients with pheochromocytoma. | Secondary outcome measure | through study completion, an average of 1 year |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Study Central Contact
Contact: Peipei Wang, MD, 86 18511395988, [email protected]
2 Study Locations in 1 Countries
Zhejiang
The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China
Xinhui Su, MD, Contact, 86 13806071262, [email protected]
Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310006, China
Peipei Wang, MD, Contact, 86 18511395988, [email protected]
Xinhui Su, MD, Contact, 86 13806071262, [email protected]
Recruiting