Using 18F-MFBG PET/CT to evaluate neural crest tumors
Official title: A Study of 18F-MFBG Imaging for the Tumor Burden Evaluation or Diagnostic Performance in Pheochromocytoma, Paraganglioma and Neuroblastoma.
Run by Peking Union Medical College Hospital · NCT05069220 · Data updated 2026-11-12
This study is testing a new imaging method using 18F-MFBG to see if it can help diagnose and better understand tumors like pheochromocytoma, paraganglioma, and neuroblastoma in patients.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 80 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Dongcheng) |
| Status | Recruiting |
| Started | September 1, 2021 |
| Main results expected | September 2025 |
| Study ends | December 2026 |
| Registry record updated | March 1, 2024 |
| Trial ID | NCT05069220 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with histologically confirmed or clinically suspected neuroendocrine tumors such as pheochromocytoma, paraganglioma, or neuroblastoma.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have undergone recent surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) PET imaging in patients with neuroendocrine tumors, specifically pheochromocytoma, paraganglioma, and neuroblastoma. The study will evaluate the safety profile and image quality of 18F-MFBG, which targets the norepinephrine transporter (NET) expressed in these tumors. Unlike traditional imaging methods, 18F-MFBG allows for earlier imaging after injection, potentially improving diagnosis and treatment planning. Patients with confirmed or suspected neural crest tumors will be prospectively recruited for this evaluation.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and timely diagnoses of neural crest tumors, improving patient outcomes.
How similar studies have gone: Preliminary data suggest that similar imaging approaches have shown promise, but this specific use of 18F-MFBG is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed. Patients with histologically confirmed or clinically suspicious neural crest tumor. For patients with neuroblastoma, subject should have a routine clinical 123I-MIBG scintigraphy (planar + SPECT/CT) performed within 6 months prior to the inclusion visit or scheduled within 3 months after the inclusion visit. The subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal. The subject is able and willing to comply with all study procedures as described in the protocol. Exclusion Criteria: \- Patients are potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding. Patients undergo surgery between the selection and inclusion visit. Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating. Patients who are not suitable to participate in the trial according to researchers.
Where it's running
-
Peking union medical college hospital
Beijing, Dongcheng, China Recruiting
Study contacts
- Principal investigator: Fang Li — Peking Union Medical College Hospital
- Study coordinator: Peipei Wang
- Email: wpp199411@163.com
- Phone: 18511395988
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.