Using 18F-MFBG PET/CT to evaluate neural crest tumors
A Study of 18F-MFBG Imaging for the Tumor Burden Evaluation or Diagnostic Performance in Pheochromocytoma, Paraganglioma and Neuroblastoma.
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 |
| Enrollment | 150 (estimated) |
| Ages | 1 Year to 80 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Dongcheng) |
| Trial ID | NCT05069220 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed or clinically suspected neuroendocrine tumors such as pheochromocytoma, paraganglioma, or neuroblastoma.
Not a fit: Patients who are pregnant, breastfeeding, or have undergone recent surgery may not benefit from this study.
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 performed: Preliminary data suggest that similar imaging approaches have shown promise, but this specific use of 18F-MFBG is relatively novel.
Eligibility criteria
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 this trial is running
Beijing, Dongcheng
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.