Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT04689893
Status:
UNKNOWN
Last Update Posted:
2021-01-05
First Post:
2020-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in the Diagnosis and Evaluation of TIO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537751', 'term': 'Oncogenic osteomalacia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C513399', 'term': 'gallium Ga 68 dotatate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-02', 'studyFirstSubmitDate': '2020-12-28', 'studyFirstSubmitQcDate': '2020-12-28', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic value', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Sensitivity and Specificity of 68Ga-DOTA-JR11 PET/CT for TIO in comparison with 68Ga-DOTATATE PET/CT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tumor-Induced Osteomalacia']}, 'referencesModule': {'references': [{'pmid': '35280786', 'type': 'DERIVED', 'citation': 'Hou G, Zhang Y, Liu Y, Wang P, Xia W, Xing X, Huo L, Li F, Jing H. Head-to-Head Comparison of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in Patients With Tumor-Induced Osteomalacia: A Prospective Study. Front Oncol. 2022 Feb 24;12:811209. doi: 10.3389/fonc.2022.811209. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label whole-body PET/CT study for investigating the value of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in patients with Tumor-induced osteomalacia.', 'detailedDescription': 'Tumor-induced osteomalacia (TIO), also known as oncogenic osteomalacia, is a rare paraneoplastic syndrome. The key to the cure of TIO is surgical resection of the culprit tumor. Over the last decade, 68Ga-labeled SSTR-based imaging has made a significant impact in detecting the culprit tumor of TIO 68Ga-DOTA-TATE is the most used SSTR PET tracer for the detection of TIO and it was recommended as first-line imaging method for localization of the causative tumor.\n\nHowever, false positive, including fracture and/or inflammation, in 68Ga-DOTA-TATE PET/CT is a challenge in image interpretation, which may make the causative tumor indistinguishable in multiple suspicious lesions. There is no effective way to identify multiple suspicious lesions with intensive increased uptake on 68Ga-DOTA-TATE PET/CT.\n\n68Ga-DOTA-JR11 is a SSTR2 specific antagonist used for PET tracer. However, the SSTR2 affinity of 68Ga-DOTA-JR11 is lower than 68Ga-DOTA-TATE, which means that the uptake of 68Ga-DOTA-JR11 by suspected lesions may be lower than that of 68Ga-DOTA-TATE. The purpose of this prospective study is to compare the sensitivity of 68Ga-DOTA-JR11 and 68Ga-DOTA-TATE PET/CT for detecting the responsible tumor of TIO and investigate if 68Ga-DOTA-JR11 PET/CT can identify the culprit tumor of TIO in multiple suspicious lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspected or confirmed untreated TIO patients;\n* 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT within two weeks;\n* signed written consent.\n\nExclusion Criteria:\n\n* pregnancy;\n* breastfeeding;\n* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.'}, 'identificationModule': {'nctId': 'NCT04689893', 'briefTitle': 'Application of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in the Diagnosis and Evaluation of TIO', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Head-to-head Comparison of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in Patients With Tumor-induced Osteomalacia', 'orgStudyIdInfo': {'id': 'PUMCHTIOJR11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT scan', 'description': 'Patients of Tumor-induced osteomalacia PET/CT imaging: The patients were subcutaneously injected with 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 and underwent PET/CT scan 20\\~40min after the injection in two consecutive days.', 'interventionNames': ['Drug: 68Ga-Dotatate', 'Drug: 68Ga-DOTA-JR11']}], 'interventions': [{'name': '68Ga-Dotatate', 'type': 'DRUG', 'otherNames': ['68Ga-Dotatate injection'], 'description': '68Ga-Dotatate was injected into the patients before the PET/CT scans', 'armGroupLabels': ['68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT scan']}, {'name': '68Ga-DOTA-JR11', 'type': 'DRUG', 'otherNames': ['68Ga-DOTA-JR11 injection'], 'description': '68Ga-DOTA-JR11 was injected into the patients before the PET/CT scans', 'armGroupLabels': ['68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100010', 'city': 'Beijing', 'state': 'Dongcheng', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guozhu Hou', 'role': 'CONTACT', 'email': '15611145656@163.com', 'phone': '15611145656'}], 'facility': 'Peking union medical college hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Guozhu Hou, MD', 'role': 'CONTACT', 'email': '15611145656@163.com', 'phone': '15611145656'}], 'overallOfficials': [{'name': 'Hongli Jing, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}