A Study of 18F-MFBG Imaging for the Tumor Burden Evaluation or Diagnostic Performance in Pheochromocytoma, Paraganglioma and Neuroblastoma.

Who is this study for? Patients with Neuroendocrine Tumor
What treatments are being studied? 18F-MFBG
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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 neuroendocrine tumors mainly in pheochromocytoma and paraganglioma (PPGL) and neuroblastoma (NB).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 80
Healthy Volunteers: f
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• \- 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.

Locations
Other Locations
China
Peking union medical college hospital
RECRUITING
Beijing
Contact Information
Primary
Peipei Wang
wpp199411@163.com
18511395988
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 150
Treatments
Experimental: 18F-MFBG PET/CT in neuroendocrine malignancies
Each patient receive a single intravenous injection of 18F-MFBG 2-4 MBq/kg and undergo PET/CT scan after 60 min post-injection. Patients with neuroblastoma should have a routine clinical 123I-MIBG scintigraphy (planar and/or SPECT/CT) performed within 6 months prior to the inclusion visit or scheduled within 3 months after the inclusion visit. According to patients' condition and clinical management, part of patients with PPGL and NB will receive 68Ga-DOTATATE PET/CT, comparing with 18F-MFBG PET/CT.
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov