An Investigational Scan (Intravoxel Incoherent Motion Diffusion Weighted Imaging) for the Evaluation of Colorectal Cancer Liver Metastases Treatment Response
Evaluation of Treatment Response of Colorectal Cancer Liver Metastases With Intravoxel Incoherent Motion Diffusion Weighted Imaging
2 other identifiers
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2020
CompletedFirst Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedJanuary 14, 2026
January 1, 2026
5.5 years
October 21, 2020
January 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change in the true diffusion coefficient (D)
The absolute changes of parameter D between response and nonresponse groups will be compared using a two-sample t-test.
Up to 3 months or 5 months (each cycle is 28 days)
Secondary Outcomes (1)
Diffusion related parameters in intravoxel incoherent motion diffusion weighted imaging
Up to 3 months or 5 months (each cycle is 28 days)
Study Arms (1)
Diagnostic (IVIM DWI)
EXPERIMENTALPatients 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.
Interventions
Undergo IVIM DWI
Eligibility Criteria
You may qualify if:
- 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
- Patients with at least 1 colorectal liver metastasis measuring at least 1 cm
- Patients with anticipated follow-up before and after surgery at MD Anderson
You may not qualify if:
- 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
- Patients allergic to gadolinium
- Patients with pacemakers
- Greater than 400 pounds in weight
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Priya R Bhosale
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2020
First Posted
March 15, 2021
Study Start
August 12, 2020
Primary Completion
January 31, 2026
Study Completion
January 31, 2026
Last Updated
January 14, 2026
Record last verified: 2026-01