Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT01524016
Status:
UNKNOWN
Last Update Posted:
2017-04-07
First Post:
2012-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
68Ga-DOTATATE PET/CT in Oncogenic Osteomalacia
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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-05', 'studyFirstSubmitDate': '2012-01-29', 'studyFirstSubmitQcDate': '2012-01-29', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and location of lesions detected by 68GA-DOTATATE PET/CT compared to 99mTc-HYNIC-TOC SPECT/CT and/or 18F-FDG PET/CT', 'timeFrame': '1 year', 'description': 'Determine if the 68Ga-DOTATATE PET/CT changes care plans compared to conventional imaging/diagnostic techniques (99mTc-HYNIC-TOC SPECT/CT, and/or 18F-FDG PET/CT, MRI, CT, ultrasonography).'}], 'secondaryOutcomes': [{'measure': 'Number of participants and kinds of adverse events as a measure of safety', 'timeFrame': 'One year', 'description': 'Determine if any adverse effects are associated with the scan and the number of patients that experience them.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oncogenic osteomalacia', 'mesenchymal tumor', 'Somatostatin receptor', '68Ga-DOTATATE', 'PET/CT'], 'conditions': ['Oncogenic Osteomalacia', 'Mesenchymal Tumor']}, 'descriptionModule': {'briefSummary': 'Oncogenic osteomalacia is rare disease predominantly caused by a small, somatostatin receptor positive mesenchymal tumor, which is frequently hidden in an unusual anatomical site and often goes undetected by conventional imaging. A permanent cure of the disease relies on exactly localizing the tumor and completely removing it. 68Ga-DOTATATE PET/CT is a novel scan that might have improved sensitivity and resolution specifically for somatostatin receptor positive tumors. The investigators will scan the suspicious and confirmed patients of oncogenic osteomalacia and compare it to 99mTc-HYNIC-TOC SPECT/CT and 18F-FDG PET/CT to see if it improves patient care.', 'detailedDescription': 'Oncogenic osteomalacia, or tumor-induced osteomalacia, is a rare, serious paraneoplastic syndrome. It is predominantly driven by a small, benign mesenchymal tumor. The disease is readily prompted by the clinical features such as hyperphosphaturia, hypophosphatemia, low serum vitamin D3 levels, elevated serum fibroblast growth factor 23 levels, and osteomalacia. However, the causative tumor is frequently hidden in an unusual anatomical site and often goes undetected by conventional imaging, such as computed tomography (CT), while a permanent cure of the disease will only rely on exact localization and completely removal of the tumor.\n\nSince mesenchymal tumors express somatostatin receptors (SSR), molecular imaging using radiolabeled somatostatin analogs may be one of the best ways to detect the small, occult tumors. 111In- and 99mTc-labeled octreotide and analogs have been proved useful to detect mesenchymal tumor and other SSR-positive tumors. However, the scintigraphy is insufficient to provide high-resolution images and precise anatomical information. In this study, a novel approach was proposed for exact localization of mesenchymal tumors through positron emission tomography (PET) imaging with 68Ga-DOTATATE and co-registration with CT. 68Ga-DOTATATE PET/CT is a novel method that might have improved sensitivity and resolution specifically for SSR-positive tumors, including the causative tumor of oncogenic osteomalacia.\n\nThe investigators will scan the patients in suspicion of oncogenic osteomalacia and the confirmed oncogenic osteomalacia patients in suspicion of relapse or with residual tumor after surgery, and compare it to 99mTc-HYNIC-TOC SPECT/CT and 18F-FDG PET/CT of the same patients. The aim of the study was to see if 68Ga-DOTATATE PET/CT can detect more tumors with higher resolution and more exact localization, and then help to develop optimal treatment strategy and improves patient care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In suspicion of oncogenic osteomalacia according to the clinical features such as hyperphosphaturia, hypophosphatemia, low serum vitamin D3 levels, and osteomalacia. Or prior oncogenic osteomalacia patients in suspicion of relapse or with residual tumor\n* At least 18 years old\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Females planning to bear a child recently or with childbearing potential\n* Renal function: serum creatinine \\>3.0 mg/dL (270 μM/L)\n* Liver function: any hepatic enzyme level more than 5 times upper limit of normal.\n* Known severe allergy or hypersensitivity to IV radiographic contrast.\n* Patients not able to enter the bore of the PET/CT scanner.\n* Inability to lie still for the entire imaging time because of cough, pain, etc.\n* Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.\n* Any other medical condition that, in the opinion of the Investigator, may significantly interfere with study compliance.'}, 'identificationModule': {'nctId': 'NCT01524016', 'briefTitle': '68Ga-DOTATATE PET/CT in Oncogenic Osteomalacia', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': '68Ga-DOTATATE PET/CT for Detection and Evaluation of the Causative Tumor of Oncogenic Osteomalacia', 'orgStudyIdInfo': {'id': 'PUMCHNM001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-DOTATATE, PET/CT scan', 'description': 'We will perform 68Ga-DOTATATE PET/CT scanning on subjects', 'interventionNames': ['Drug: 68Ga-DOTATATE']}], 'interventions': [{'name': '68Ga-DOTATATE', 'type': 'DRUG', 'otherNames': ['(68)Ga-DOTA-d-Phe(1),Tyr(3)-octreotate'], 'description': 'Intravenous injection of one dosage of 72-185MBq (2-5 mCi) 68Ga-DOTATATE solution. Tracer doses of 68Ga-DOTATATE will be used to image tumors by Positron Emission Tomography / computed tomography (PET/CT)', 'armGroupLabels': ['68Ga-DOTATATE, PET/CT scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Li, MD', 'role': 'CONTACT', 'email': 'lifang@pumch.cn', 'phone': '86-10-65295502'}, {'name': 'Zhaohui Zhu, MD, PhD', 'role': 'CONTACT', 'email': 'zzh_1969@yahoo.com.cn', 'phone': '86-10-13611093752'}, {'name': 'Fang Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zhaohui Zhu, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hongli Jing, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Nuclear Medicine, Peking Union Medical College Hopital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Fang Li, MD', 'role': 'CONTACT', 'email': 'lifang@pumch.cn', 'phone': '86-10-65295502'}, {'name': 'Zhaohui Zhu, MD, PhD', 'role': 'CONTACT', 'email': 'zzh_1969@yahoo.com.cn', 'phone': '86-10-13611093752'}], 'overallOfficials': [{'name': 'Fang Li, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Nuclear Medicine, Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}