18F-MFBG: Patients with neuroendocrine malignancies receive 2-4 MBq/kg of 18F-MFBG intravenously followed by PET/CT after 60min of injection.
68Ga-Dotatate: Patients with malignant PPGL and NB receive intravenously 68Ga-Dotatate followed by PET/CT after 40min of injection.
Study 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
Sex
ALL
Min age
1 Year
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
The evaluation of diagnostic performance of 18F-MFBG PET in different regions in metastatic neural crest tumor. — through study completion, an average of 1 year Patients with histologically confirmed metastatic neural crest tumor will be prospectively recruited in this study. They will receive 18F-MFBG PETand 123I-MIBG SPECT. Rate of detected lesions (visual) in bone, lymph node and liver will be compared.
Trial sites (1)
Facility
City
Region
Status
Peking union medical college hospital
Beijing
Dongcheng
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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