18F-MFBG PET/CT in the Evaluation of Neuroendocrine Malignancies

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital

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 multifocal and/or metastatic neural crest tumor.

Subject should have a routine clinical 131I-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.