An Investigational Scan (Intravoxel Incoherent Motion Diffusion Weighted Imaging) for the Evaluation of Colorectal Cancer Liver Metastases Treatment Response

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Stage IVC Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Metastatic Malignant Neoplasm in the Liver; Stage IVA Colorectal Cancer AJCC v8; Resectable Colorectal Carcinoma; Stage IVB Colorectal Cancer AJCC v8; Metastatic Colorectal Carcinoma

Treatments: Procedure: Diffusion Weighted Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04796818

NCI-2020-07466 (Registry Identifier)

2020-0004 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

70 participants in 1 patient group

Diagnostic (IVIM DWI)

Experimental group

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.

Treatment:

Procedure: Diffusion Weighted Imaging