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
Conditions
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.
Detailed description
PRIMARY OBJECTIVE: I. 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. SECONDARY OBJECTIVES: I. Use respiratory-triggered DWI and quantitative T2 maps for the evaluation of colorectal liver metastases (CLM) after treatment. II. Assess whether changes in these parameters correlate to pathologic treatment response (percent necrosis) determined on pathology. OUTLINE: 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
PROCEDUREDiffusion Weighted Imaging
Undergo IVIM DWI
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in the true diffusion coefficient (D) | Up to 3 months or 5 months (each cycle is 28 days) | The absolute changes of parameter D between response and nonresponse groups will be compared using a two-sample t-test. |
Secondary
| Measure | Time frame |
|---|---|
| Diffusion related parameters in intravoxel incoherent motion diffusion weighted imaging | Up to 3 months or 5 months (each cycle is 28 days) |
Countries
United States
Contacts
Primary ContactPriya R Bhosale
Outcome results
None listed