18F-MFBG PET/CT in the Evaluation of Neuroendocrine Malignancies
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Early Phase 1 |
Detailed Description
Pheochromocytoma and paraganglioma (PPGL) and neuroblastoma (NB) highly express norepinephrine transporter (NET) which is targeted by functional analogue of norepinephrine, 131I/123I-MIBG. However, low spatial resolution of 123/131I-MIBG and inaccurate attenuation correction of single photon emission tomography (SPECT/CT) will affect the image quality of MIBG SPECT and lead to poor diagnosis of small lesions. In addition, 123I-MIBG imaging is usually performed at 24 h after injection, while 131I-MIBG is performed at 48 h or even 72 h after injection. The procedure is complicated and takes a long time, which limits clinical application. 18F-labeled MFBG is an ideal tracer to show the expression of NET. Preliminary data show that 18F-MFBG imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. Patients can undergo PET 0.5 hours after injection without special preparation. Our study will assess the safety profile, image quality and evaluate the diagnostic performance and tumor burden of 18F-MFBG. Patients with histologically confirmed multifocal and/or metastatic neural crest tumor will be prospectively recruited in this study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 18F-MFBG PET/CT in neuroendocrine malignancies Each patient receive a single intravenous injection of 18F-MFBG 148-444 MBq (4- 12mCi) and undergo PET/CT scan at 60-90 min post-injection. All patients should have a routine clinical 131I-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. |
Drug: 18F-MFBG
Patients with neuroendocrine malignancies receive 148-444 MBq (4- 12mCi) of 18F-MFBG intravenously followed by PET/CT after 60-90min of injection.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 131I-MIBG SPECT. Rate of detected lesions (visual) in bone, lymph node and liver will be compared.
Secondary Outcome Measures
- Assessment of lesion targeting by 18F-MFBG as compared to 68Ga-DOTATATE [through study completion, an average of 2 years]
A lesion-by-lesion analysis will be performed to compare the number of detected lesions using 18F-MFBG and 68Ga-DOTATATE.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking union medical college hospital | Beijing | Dongcheng | China | 100010 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Fang Li, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZS-3060MFBG