New imaging technique to evaluate treatment response in colorectal cancer that has spread to the liver
Evaluation of Treatment Response of Colorectal Cancer Liver Metastases With Intravoxel Incoherent Motion Diffusion Weighted Imaging
This study is testing a new imaging method to see if it can help doctors tell how well chemotherapy is working for people with colorectal cancer that has spread to the liver.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04796818 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of intravoxel incoherent motion diffusion weighted imaging (IVIM DWI) in detecting changes in colorectal cancer liver metastases before and after chemotherapy. The primary goal is to determine if IVIM DWI can differentiate between responders and nonresponders to treatment based on diffusion-related parameters. Additionally, the study will assess correlations between imaging changes and pathological treatment responses. Patients will undergo IVIM DWI scans during standard MRI procedures at specified intervals during their chemotherapy regimen.
Who should consider this trial
Good fit: Ideal candidates include treatment-naive patients with resectable colorectal liver metastases who are starting specific chemotherapy regimens.
Not a fit: Patients who have previously received chemotherapy for their liver metastases or those undergoing other non-surgical therapies will not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging technique could provide a non-invasive method to better assess treatment responses in patients with colorectal cancer liver metastases.
How similar studies have performed: While the use of IVIM DWI is a novel approach, similar imaging techniques have shown promise in evaluating treatment responses in other cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Priya R Bhosale — M.D. Anderson Cancer Center
- Study coordinator: Priya R Bhosale
- Email: priya.bhosale@mdanderson.org
- Phone: 713-792-0221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.