18F-MFBG PET/CT in the Evaluation of Neural Crest Tumor
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age1-80
SponsorPeking Union Medical College Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
18F-MFBG
DrugPatients with neuroendocrine malignancies receive 2-4 MBq/kg of 18F-MFBG intravenously followed by PET/CT after 60min of injection.
68Ga-Dotatate
DrugPatients with malignant PPGL and NB receive intravenously 68Ga-Dotatate followed by PET/CT after 40min of injection.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: 18F-MFBG PET/CT in neuroendocrine malignanciesExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The evaluation of diagnostic performance of 18F-MFBG PET in different regions in metastatic neural crest tumor.
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.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Assessment of lesion targeting by 18F-MFBG as compared to 68Ga-DOTATATE
A lesion-by-lesion analysis will be performed to compare the number of detected lesions using 18F-MFBG and 68Ga-DOTATATE.
Time frame
through study completion, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov