18F-MFBG PET/CT in the Evaluation of Neural Crest Tumor
A Study of 18F-MFBG Imaging for the Tumor Burden Evaluation or Diagnostic Performance in Pheochromocytoma, Paraganglioma and Neuroblastoma.
Peking Union Medical College Hospital
150 participants
Sep 1, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- \- 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 Criteria2
- \- 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.
Interventions
Patients with neuroendocrine malignancies receive 2-4 MBq/kg of 18F-MFBG intravenously followed by PET/CT after 60min of injection.
Patients with malignant PPGL and NB receive intravenously 68Ga-Dotatate followed by PET/CT after 40min of injection.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05069220