Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-29 @ 12:33 AM
Study NCT ID:
NCT05250895
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2021-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BOLD MRI and FMISO PET for the Assessment of Hypoxic Tumor Microenvironment in Patients with Oligometastatic Liver Cancer Undergoing Yttirum-90 Selective Internal Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031843', 'term': 'fluoromisonidazole'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2022-02-21', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the variability of hypoxia in HCC at baseline as quantified by BOLD MRI', 'timeFrame': 'From weeks 1-2 up to 1 year', 'description': 'Threshold \\<1.0 R2 tumor to normal ratio (no unit) as a cutoff for hypoxia'}, {'measure': 'To investigate the variability of hypoxia in HCC at baseline as quantified by immunohistochemistry', 'timeFrame': 'From weeks 1-2 up to 1 year', 'description': 'The staining intensity will be measured and scored with four scales: no staining=0, weak staining=1, moderate staining=2, and strong staining=3. The final staining score will be obtained by stained stumor area% x positive tumor cells % x staining intensity. The tumors will be then categorized as hypoxic (scores 8 to 16) vs. non-hypoxic (scores 0 to 7) (no units).'}], 'secondaryOutcomes': [{'measure': 'Determine whether hypoxia is predictor of response in HCC treated with Y90 SIRT', 'timeFrame': 'From week 0 up to 1 year', 'description': 'Treatment Response Assessment using mRECIST'}, {'measure': 'Treatment response', 'timeFrame': 'From week 0 Up to 1 year', 'description': 'Assessed using modified Response Evaluation Criteria in Solid Tumors.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['BCLC Stage a Hepatocellular Carcinoma', 'BCLC Stage B Hepatocellular Carcinoma', 'BCLC Stage C Hepatocellular Carcinoma', 'Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This early phase I trial evaluates the use of hypoxia (lack of oxygen) as a measure in determining the outcome of Y90 selective internal radiation therapy in patients with liver cancer that has spread to a limited number of sites (oligometastatic). Radioembolization with Y90 is a minimally invasive procedure that combines embolization and radiation therapy to treat metastatic liver cancer. Tiny beads filled with radioactive isotope Y-90 are placed inside the blood vessel that provide blood supply to the tumor. This will block the blood flow to the tumor cells while providing a high radiation dose without harming healthy normal tissue.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To investigate the variability of hypoxia in hepatocellular carcinoma (HCC) as quantified by blood oxygen level-dependent (BOLD) magnetic resonance imaging (MRI) and dynamic 18F-Fluoromisonidazole (FMISO) positron emission tomography (PET).\n\nSECONDARY OBJECTIVES:\n\nI. Investigate whether hypoxia, as quantified by BOLD MRI, dynamic FMISO PET, HIF-1alpha and VEGF expression, predicts HCC response to yttrium-90 (Y90) selective internal radiation therapy (SIRT).\n\nII. Assess whether hypoxia quantification by BOLD MRI, dynamic FMISO, HIF-1alpha or VEGF expression individually or in combination more accurately predict the degree of HCC tumor response to Y90 SIRT.\n\nIII. Compare the tumor dose response threshold between hypoxic and non-hypoxic HCCs treated with Y90 SIRT.\n\nOUTLINE:\n\nPatients receive 18F-fluoromisonidazole intravenously (IV) and undergo PET and dynamic contrast enhanced (DCE) MRI within 30 days before beginning Y90 SIRT. Patients undergo Y90 SIRT per standard of care.\n\nAfter completion of study intervention, patients are followed up at 90 days, and then every 12 weeks thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years\n* Established HCC diagnosis, unilobar or bilobar disease\n* At least 1 tumor \\>= 3 cm\n* Oligometastatic disease\n* Barcelona Clinic Liver Cancer (BCLC) stage A, B or C\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\< 2 (Karnofsky \\>= 60%)\n* Life expectancy \\> 12 weeks as determined by the Investigator\n* The effects of Y90 Radioembolization on the developing human fetus are unknown. For this reason, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy\n* FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months\n\nExclusion Criteria:\n\n* Patients who are definite transplant candidates\n* Concurrent second malignancy outside of the liver\n* Infiltrative liver tumor\n* Previous liver-directed therapy to targeted tumors\n* BCLC stage D\n* Bilirubin \\> 2 mg/dL for lobar treatment and bilirubin \\> 3 mg/dL for segmental or bi-segmental Y90-SIRT\n* Albumin \\< 3 g/dL\n* Projected lung dose of \\> 30 Gy in a single session to the liver after prospective treatment planning\n* Body mass index (BMI) \\> 40'}, 'identificationModule': {'nctId': 'NCT05250895', 'briefTitle': 'BOLD MRI and FMISO PET for the Assessment of Hypoxic Tumor Microenvironment in Patients with Oligometastatic Liver Cancer Undergoing Yttirum-90 Selective Internal Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Molecular Imaging of the Hypoxic Tumor Microenvironment to Predict Response to Yttirum-90 Selective Internal Radiation Therapy in Hepatocellular Carcinoma- Pilot Study', 'orgStudyIdInfo': {'id': 'STUDY00002804'}, 'secondaryIdInfos': [{'id': 'NCI-2021-09943', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'STUDY00002804'}, {'id': 'RAD5342-21', 'type': 'OTHER', 'domain': 'Emory University Hospital/Winship Cancer Institute'}, {'id': 'P30CA138292', 'link': 'https://reporter.nih.gov/quickSearch/P30CA138292', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (18F-fluoromisonidazole, PET, DCE MRI)', 'description': 'Patients receive 18F-fluoromisonidazole IV and undergo PET and DCE MRI within 30 days before beginning Y90 SIRT. Patients undergo Y90 SIRT per standard of care.', 'interventionNames': ['Other: 18F-Fluoromisonidazole', 'Procedure: Biopsy', 'Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging', 'Procedure: Positron Emission Tomography']}], 'interventions': [{'name': '18F-Fluoromisonidazole', 'type': 'OTHER', 'otherNames': ['18F-MISO', '18F-Misonidazole', 'FMISO'], 'description': 'Given IV', 'armGroupLabels': ['Diagnostic (18F-fluoromisonidazole, PET, DCE MRI)']}, {'name': 'Biopsy', 'type': 'PROCEDURE', 'otherNames': ['BIOPSY_TYPE', 'Bx'], 'description': 'Undergo biopsy', 'armGroupLabels': ['Diagnostic (18F-fluoromisonidazole, PET, DCE MRI)']}, {'name': 'Dynamic Contrast-Enhanced Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['DCE', 'DCE MRI', 'DCE-MRI', 'DYNAMIC CONTRAST ENHANCED MRI'], 'description': 'Undergo DCE MRI', 'armGroupLabels': ['Diagnostic (18F-fluoromisonidazole, PET, DCE MRI)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging'], 'description': 'Undergo PET', 'armGroupLabels': ['Diagnostic (18F-fluoromisonidazole, PET, DCE MRI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital/Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Nima Kokabi, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Brandon', 'investigatorAffiliation': 'Emory University'}}}}