Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-02-21 @ 9:48 PM
Study NCT ID:
NCT01879657
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2013-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C513399', 'term': 'gallium Ga 68 dotatate'}, {'id': 'D000072078', 'term': 'Positron Emission Tomography Computed Tomography'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'dispFirstSubmitDate': '2023-03-23', 'completionDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2013-04-11', 'studyFirstSubmitQcDate': '2013-06-13', 'dispFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique', 'timeFrame': 'SOT within 28 days before 68Ga-DOTATATE PET/CT scan', 'description': 'We want to determine if the 68Ga-DOTATATE PET/CT scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI).'}], 'secondaryOutcomes': [{'measure': 'Frequency and severity of Adverse Events', 'timeFrame': '4 days', 'description': 'Adverse events will be collected from the time of 68Ga-DOTATATE injection until 48 hours post-injection visit. Adverse events will be classified using criteria for adverse events (CTCAE) Version 4.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neuroendocrine Carcinoma']}, 'descriptionModule': {'briefSummary': 'To evaluate the concordance and discordance between results of 68Ga-DOTATATE PET-CT scan and OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers and other imaging modalities like CT scan/MRI as gold standard.', 'detailedDescription': 'The number of lesions that could be identified clearly as single foci will be determined for each patient. The same anatomic areas will be imaged with 68Ga-DOTATATE PET and 111In-penteoctreotide Scintigraphy to ensure relevant comparison of lesion detection. Because of confluence and inability to clearly delineate single liver lesions in some cases, liver metastases will be classified as 1 organ metastasis, independent of the number of liver metastases present. Lymph nodes smaller than 1 cm on CT or MRI and showing marked avidity for 68Ga- DOTATATE and 111In-penteoctreotide will be labeled as positive for disease. The presence of lesions will be confirmed by cross-sectional imaging of all patients with CT or MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Subjects of either sex, aged ≥18 years\n* Histologically and/or clinically confirmed and/or suspected NET and/or A diagnostic imaging study including but not limited to CT or MRI or FDG PET/CT, NaF PET/CT, bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day\n* Recent Blood test results (within 2-4 weeks predose) as WBC: ≥2 x 109/L, Haemoglobin: ≥8.0 g/dL, Platelets: ≥50 x 109/L, ALT, AST, AP:≤ 5 times ULN \\[ ULN for ALT, AST and AP is 70, 20 and 20 Units/I respectively\\], Bilirubin: ≤3 times ULN \\[ULN for total bilirubin is 1.3mg/dL\\]\n* Serum creatinine: Serum creatinine: \\<170 μmol/L\n* egative pregnancy test in women capable of child-bearing\n\nExclusion Criteria:\n\n* Known hypersensitivity to DOTA, to 68Gallium, to Octreotate or to any of the excipients of 68Ga-DOTATATE\n* Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug\n* Pregnant or breast-feeding women\n* Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study'}, 'identificationModule': {'nctId': 'NCT01879657', 'briefTitle': '68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs)', 'organization': {'class': 'OTHER', 'fullName': 'Radio Isotope Therapy of America'}, 'officialTitle': 'An Open-label, Single-dose, Clinical Trial of 68Ga-DOTATATE (GalioMedix™) PET-CT Scan for Diagnosis of Primary and Metastatic Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)', 'orgStudyIdInfo': {'id': '117289'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-DOTATATE', 'description': 'All participants will be injected with 68Ga-DOTATATE approximately 60 minutes before PET/CT scan.', 'interventionNames': ['Drug: 68Ga-DOTATATE', 'Diagnostic Test: PET/CT', 'Diagnostic Test: 111In-pentetreotide OctreoScan', 'Diagnostic Test: MRI']}], 'interventions': [{'name': '68Ga-DOTATATE', 'type': 'DRUG', 'otherNames': ['Gallium-68 DOTATATE', '[⁶⁸Ga]-DOTA-Tyr3-Octreotate', '68Ga DOTA-TATE'], 'description': '68Ga-DOTATATE (3-5 mCi ±25%; 111-185 MBq) is administered as a single intravenous bolus injection in each participant. These injections were performed within 28 days after the Octreoscan.', 'armGroupLabels': ['68Ga-DOTATATE']}, {'name': 'PET/CT', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['PET-CT Scan'], 'description': '68Ga-DOTATATE PET images will be acquired 60 ±30 minutes after injection of 68Ga-DOTATATE. 68Ga-DOTATATE PET images were performed within 28 days after the Octreoscan.', 'armGroupLabels': ['68Ga-DOTATATE']}, {'name': '111In-pentetreotide OctreoScan', 'type': 'DIAGNOSTIC_TEST', 'description': 'OctreoScan™ was performed after intravenous injection of 111In-pentetreotide, a radiopharmaceutical that binds to somatostatin receptors, if the patient had not undergone such imaging as a standard of care. Subsequent planar and/or SPECT imaging was used to detect somatostatin receptor-positive lesions.', 'armGroupLabels': ['68Ga-DOTATATE']}, {'name': 'MRI', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Magnetic Resonance Imaging (MRI)'], 'description': 'MRI (Standard of Care)', 'armGroupLabels': ['68Ga-DOTATATE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77042', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Radio- Isotope Therapy of America', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ebrahim Delpassand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiomedix, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radio Isotope Therapy of America', 'class': 'OTHER'}, 'collaborators': [{'name': 'Radiomedix, Inc.', 'class': 'INDUSTRY'}, {'name': 'Excel Diagnostics and Nuclear Oncology Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Ebrahim Delpassand', 'investigatorAffiliation': 'Radio Isotope Therapy of America'}}}}