Recruiting

Investigational Scan

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04796818

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diffusion Weighted Imaging

Study Details

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.

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

Study ID

NCT04796818

Start date

Aug 12, 2020

Status verified date

Jul, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (IVIM DWI)

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.

Interventions

Diffusion Weighted Imaging

Undergo IVIM DWI

Primary outcome measure

  • Absolute change in the true diffusion coefficient (D) [ Time Frame: Up to 3 months or 5 months (each cycle is 28 days) ]

Central Contacts and Locations

Central contacts

Priya R Bhosale

713-792-0221priya.bhosale@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Priya R. Bhosale

713-792-0221

Principal Investigator:

Priya R. Bhosale

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-20.