Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT06148220
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2023-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Clinical Application of [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT Imaging in the Diagnosis of CD70-expressing Multiple Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2023-11-19', 'studyFirstSubmitQcDate': '2023-11-19', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete PET imaging', 'timeFrame': '90mins from time of injection', 'description': '1\\. Establishment and optimization of imaging method for \\[18F\\]RCCB6 or \\[68Ga\\]Ga-NOTA-RCCB6 PET/CT imaging. 2. Evaluating the sensitivity and specificity of using \\[18F\\]RCCB6 or \\[68Ga\\]Ga-NOTA-RCCB6 PET/CT in diagnosing renal cell carcinoma (especially metastatic clear cell renal carcinoma) and lymphoma.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Cancer', 'Lymphomas', 'Positron Emission Tomography']}, 'referencesModule': {'references': [{'pmid': '39510586', 'type': 'DERIVED', 'citation': 'Zhou X, Wu Q, Zhai W, Zhang Y, Wu Y, Cao M, Wang C, Guan Y, Liu J, Xie F, Wei W. CD70-Targeted Immuno-PET/CT Imaging of Clear Cell Renal Cell Carcinoma: A Translational Study. J Nucl Med. 2024 Dec 3;65(12):1891-1898. doi: 10.2967/jnumed.124.268509.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to establish and optimize the \\[18F\\]RCCB6 and \\[68Ga\\]Ga-NOTA-RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in renal cancer (especially clear cell renal cell carcinoma) and lymphoma was evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be between 18 and 65 years of age and of either sex.\n2. Affected with renal cancer or lymphoma confirmed by puncture or surgical pathology.\n3. Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver.\n4. Willingness and ability to cooperate with all programs of this study.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will be excluded from the study:\n\n 1. Severe hepatic and renal insufficiency;\n 2. Targeted therapy prior to radiotherapy or PET/CT scan. Renal function: serum creatinine less than or equal to the upper limit of the normal range;\n 3. Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.\n 4. History of serious surgery in the last month.\n 5. Those who have participated in other clinical trials during the same period.'}, 'identificationModule': {'nctId': 'NCT06148220', 'briefTitle': 'A Study of the Clinical Application of [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT Imaging in the Diagnosis of CD70-expressing Multiple Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'A Study of the Clinical Application of [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT Imaging in the Diagnosis of CD70-expressing Multiple Tumors', 'orgStudyIdInfo': {'id': 'KY2023-779'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with renal cancer', 'description': 'Intravenous injection of 3.7 MBq \\[0.1 mCi\\]/kg of \\[18F\\]RCCB6 or \\[68Ga\\]Ga-NOTA-RCCB6 in a single dose', 'interventionNames': ['Radiation: [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging']}, {'type': 'EXPERIMENTAL', 'label': 'patients with lymphoma', 'description': 'Intravenous injection of 3.7 MBq \\[0.1 mCi\\]/kg of \\[18F\\]RCCB6 or \\[68Ga\\]Ga-NOTA-RCCB6 in a single dose', 'interventionNames': ['Radiation: [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging']}], 'interventions': [{'name': '[18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging', 'type': 'RADIATION', 'description': 'Intravenous injection of 3.7 MBq \\[0.1 mCi\\]/kg of \\[18F\\]RCCB6 or \\[68Ga\\]Ga-NOTA-RCCB6 in a single dose', 'armGroupLabels': ['patients with lymphoma', 'patients with renal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yihui Guan, MD', 'role': 'CONTACT', 'email': 'guanyihui@hotmail.com', 'phone': '13764308300', 'phoneExt': '+86'}], 'facility': 'Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yihui Guan, MD', 'role': 'CONTACT', 'email': 'guanyihui@hotmail.com', 'phone': '13764308300', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Fang Xie', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'YiHui Guan', 'investigatorAffiliation': 'Huashan Hospital'}}}}