Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT05069220
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2021-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
18F-MFBG PET/CT in the Evaluation of Neural Crest Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D010673', 'term': 'Pheochromocytoma'}, {'id': 'D010235', 'term': 'Paraganglioma'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C107924', 'term': '3-fluorobenzylguanidine'}, {'id': 'C513399', 'term': 'gallium Ga 68 dotatate'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-09-25', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The evaluation of diagnostic performance of 18F-MFBG PET in different regions in metastatic neural crest tumor.', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Assessment of lesion targeting by 18F-MFBG as compared to 68Ga-DOTATATE', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'A lesion-by-lesion analysis will be performed to compare the number of detected lesions using 18F-MFBG and 68Ga-DOTATATE.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuroendocrine Tumor', 'Neuroblastoma', 'Pheochromocytoma', 'Paraganglioma']}, 'referencesModule': {'references': [{'pmid': '40717185', 'type': 'DERIVED', 'citation': 'Wang P, Yu S, Chen X, Zheng X, Mao J, Jing H, Zhuang H, Li F, Su X. [18F]MFBG PET/CT is an effective and preferable imaging modality for neuroblastoma in a prospective comparison with SSTR PET. Eur J Nucl Med Mol Imaging. 2025 Jul 28. doi: 10.1007/s00259-025-07449-y. Online ahead of print.'}, {'pmid': '37160439', 'type': 'DERIVED', 'citation': 'Wang P, Li T, Liu Z, Jin M, Su Y, Zhang J, Jing H, Zhuang H, Li F. [18F]MFBG PET/CT outperforming [123I]MIBG SPECT/CT in the evaluation of neuroblastoma. Eur J Nucl Med Mol Imaging. 2023 Aug;50(10):3097-3106. doi: 10.1007/s00259-023-06221-4. Epub 2023 May 9.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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 on nural crest tumors including PPGL and NB. Patients with histologically confirmed or clinically suspected neural crest tumor will be prospectively recruited in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 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.\n\nFor 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.\n\nThe 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.\n\nExclusion Criteria:\n\n\\- Patients are potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding.\n\nPatients 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.'}, 'identificationModule': {'nctId': 'NCT05069220', 'briefTitle': '18F-MFBG PET/CT in the Evaluation of Neural Crest Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Study of 18F-MFBG Imaging for the Tumor Burden Evaluation or Diagnostic Performance in Pheochromocytoma, Paraganglioma and Neuroblastoma.', 'orgStudyIdInfo': {'id': 'ZS-3060MFBG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-MFBG PET/CT in neuroendocrine malignancies', 'description': "Each patient receive a single intravenous injection of 18F-MFBG 2-4 MBq/kg and undergo PET/CT scan after 60 min post-injection. Patients with neuroblastoma should have a routine clinical 123I-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. According to patients' condition and clinical management, part of patients with PPGL and NB will receive 68Ga-DOTATATE PET/CT, comparing with 18F-MFBG PET/CT.", 'interventionNames': ['Drug: 18F-MFBG', 'Drug: 68Ga-Dotatate']}], 'interventions': [{'name': '18F-MFBG', 'type': 'DRUG', 'otherNames': ['18F-metafluorobenzylguanidine'], 'description': 'Patients with neuroendocrine malignancies receive 2-4 MBq/kg of 18F-MFBG intravenously followed by PET/CT after 60min of injection.', 'armGroupLabels': ['18F-MFBG PET/CT in neuroendocrine malignancies']}, {'name': '68Ga-Dotatate', 'type': 'DRUG', 'description': 'Patients with malignant PPGL and NB receive intravenously 68Ga-Dotatate followed by PET/CT after 40min of injection.', 'armGroupLabels': ['18F-MFBG PET/CT in neuroendocrine malignancies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100010', 'city': 'Beijing', 'state': 'Dongcheng', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peipei Wang', 'role': 'CONTACT', 'email': 'wpp199411@163.com', 'phone': '18511395988'}], 'facility': 'Peking union medical college hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Peipei Wang', 'role': 'CONTACT', 'email': 'wpp199411@163.com', 'phone': '18511395988'}], 'overallOfficials': [{'name': 'Fang Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}