Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 1:47 PM
Study NCT ID:
NCT05001204
Status:
UNKNOWN
Last Update Posted:
2021-08-11
First Post:
2021-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628612', 'term': '68Ga-NOTA-RM26'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-06', 'studyFirstSubmitDate': '2021-08-06', 'studyFirstSubmitQcDate': '2021-08-06', 'lastUpdatePostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized uptake value of 68Ga-NOTA-RM26 in gastrointestinal stromal tumor', 'timeFrame': '1 year', 'description': 'The quantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (suv) of the tracer in Gastrointestinal stromal tumors will be measured.'}], 'secondaryOutcomes': [{'measure': 'Adverse events collection', 'timeFrame': '1 week', 'description': 'Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET/CT', 'RM26', 'GRPR', 'gastrin-releasing peptide receptor'], 'conditions': ['Gastrointestinal Stromal Tumors']}, 'descriptionModule': {'briefSummary': 'This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in Gastrointestinal stromal tumor（GIST）patients. A single dose of 55.5 to 148 MBq(1.5-4 mCi) of 68Ga-NOTA-RM26 will be injected intravenously. Patients underwent whole-body PET/CT scans at 30-90 minutes after intravenous injection.', 'detailedDescription': 'Rm26 is a bioactive polypeptide containing 9 amino acid residues, which can specifically bind to gastrin releasing peptide receptor (GRPR, BB2 receptor). Previous studies have confirmed that there are a large number of GRPR receptors in human common types of tumors, such as lung cancer, breast cancer, prostate cancer, head and neck squamous cell carcinoma, glioma and gastrointestinal tumors. Therefore, the use of various radionuclide labeled gastrin releasing peptide receptor analogues RM26 for tumor targeted imaging and treatment greatly improves the early detection rate of tumor, and has important clinical significance and value in tumor staging, prognosis evaluation and curative effect evaluation.This prospective pilot study investigated the use of 68Ga-NOTA-RM26, an antagonist targeting gastrin-releasing peptide receptor (GRPR), for evaluating breast cancer using positron-emission tomography/computed tomography (PET/CT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in suspicion of gastrointestinal stromal tumors by CT or ultrasonography,and being able to provide basic information and sign the written informed consent form.\n\nExclusion Criteria:\n\n* The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with GRPR binding.'}, 'identificationModule': {'nctId': 'NCT05001204', 'briefTitle': '68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': '68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor', 'orgStudyIdInfo': {'id': 'PekingUMCH-NMRM26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-NOTA-RM26 PET/CT', 'description': 'Patients underwent whole-body PET/CT scans at 30-90 minutes after intravenous injection of 55.5-148 MBq (1.5-4 mCi) of 68Ga-NOTA-RM26.', 'interventionNames': ['Drug: 68Ga-NOTA-RM26']}], 'interventions': [{'name': '68Ga-NOTA-RM26', 'type': 'DRUG', 'description': '68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans', 'armGroupLabels': ['68Ga-NOTA-RM26 PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rongxi Wang', 'role': 'CONTACT', 'email': 'pumch_jacobwong@163.com', 'phone': '+8619800370331'}], 'facility': 'Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Rongxi Wang', 'role': 'CONTACT', 'email': 'pumch_jacobwong@163.com', 'phone': '+8619800370331'}, {'name': 'Zhaohui Zhu, MD', 'role': 'CONTACT', 'email': '13611093752@163.com', 'phone': '13611093752'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}