Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT04796818
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2020-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Investigational Scan (Intravoxel Incoherent Motion Diffusion Weighted Imaging) for the Evaluation of Colorectal Cancer Liver Metastases Treatment Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2020-10-21', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change in the true diffusion coefficient (D)', 'timeFrame': 'Up to 3 months or 5 months (each cycle is 28 days)', 'description': 'The absolute changes of parameter D between response and nonresponse groups will be compared using a two-sample t-test.'}], 'secondaryOutcomes': [{'measure': 'Diffusion related parameters in intravoxel incoherent motion diffusion weighted imaging', 'timeFrame': 'Up to 3 months or 5 months (each cycle is 28 days)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Colorectal Carcinoma', 'Metastatic Malignant Neoplasm in the Liver', 'Resectable Colorectal Carcinoma', 'Stage IV Colorectal Cancer AJCC v8', 'Stage IVA Colorectal Cancer AJCC v8', 'Stage IVB Colorectal Cancer AJCC v8', 'Stage IVC Colorectal Cancer AJCC v8']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This trial evaluates the treatment response of colorectal cancer that has spread to the liver (liver metastases) using intravoxel incoherent motion diffusion weighted imaging (IVIM DWI). IVIM DWI is new kind of imaging scan that may help measure changes in disease before and after chemotherapy in patients with colorectal liver metastases.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine whether intravoxel incoherent motion (IVIM) diffusion weighted imaging (DWI) can detect a difference between the changes in the diffusion related parameters in patients before and after chemotherapy between responders and nonresponders.\n\nSECONDARY OBJECTIVES:\n\nI. Use respiratory-triggered DWI and quantitative T2 maps for the evaluation of colorectal liver metastases (CLM) after treatment.\n\nII. Assess whether changes in these parameters correlate to pathologic treatment response (percent necrosis) determined on pathology.\n\nOUTLINE:\n\nPatients undergo IVIM DWI over 10 minutes during standard of care MRI within 30 days of starting chemotherapy and after 4-6 cycles of preoperative chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with treatment-naive resectable CLM, who will start chemotherapy with oxaliplatin with fluorouracil (5-FU)/leucovorin (FOLFOX), irinotecan with 5-FU/leucovorin (FOLFIRI), or a combination, such as fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFOXIRI), with or without a biologic agent\n* Patients with at least 1 colorectal liver metastasis measuring at least 1 cm\n* Patients with anticipated follow-up before and after surgery at MD Anderson\n\nExclusion Criteria:\n\n* Patients who have already received preoperative chemotherapy for the CLM or will undergo radiation therapy, ablative therapies, or other non-surgical therapies directed at the liver\n* Patients allergic to gadolinium\n* Patients with pacemakers\n* Greater than 400 pounds in weight'}, 'identificationModule': {'nctId': 'NCT04796818', 'briefTitle': 'An Investigational Scan (Intravoxel Incoherent Motion Diffusion Weighted Imaging) for the Evaluation of Colorectal Cancer Liver Metastases Treatment Response', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Evaluation of Treatment Response of Colorectal Cancer Liver Metastases With Intravoxel Incoherent Motion Diffusion Weighted Imaging', 'orgStudyIdInfo': {'id': '2020-0004'}, 'secondaryIdInfos': [{'id': 'NCI-2020-07466', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2020-0004', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (IVIM DWI)', 'description': 'Patients undergo IVIM DWI over 10 minutes during standard of care MRI within 30 days of starting chemotherapy and after 4-6 cycles of preoperative chemotherapy.', 'interventionNames': ['Procedure: Diffusion Weighted Imaging']}], 'interventions': [{'name': 'Diffusion Weighted Imaging', 'type': 'PROCEDURE', 'otherNames': ['Diffusion Weighted MRI', 'Diffusion-Weighted Magnetic Resonance Imaging', 'Diffusion-Weighted MR Imaging', 'Diffusion-Weighted MRI', 'DW-MRI', 'DWI', 'DWI MRI', 'DWI-MRI', 'MR Diffusion-Weighted Imaging'], 'description': 'Undergo IVIM DWI', 'armGroupLabels': ['Diagnostic (IVIM DWI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Priya R. Bhosale', 'role': 'CONTACT', 'phone': '713-792-0221'}, {'name': 'Priya R. Bhosale', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Priya R Bhosale', 'role': 'CONTACT', 'email': 'priya.bhosale@mdanderson.org', 'phone': '713-792-0221'}], 'overallOfficials': [{'name': 'Priya R Bhosale', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}