Clinical trial NCT04796818: An Investigational Scan (Intravoxel Incoherent Motion Diffusion Weighted Imaging) for the Evaluation of Colorectal Cancer Liver Metastases Treatment Response
Official title: Evaluation of Treatment Response of Colorectal Cancer Liver Metastases with Intravoxel Incoherent Motion Diffusion Weighted Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Stage IVB Colorectal Cancer AJCC V8
Stage IVC Colorectal Cancer AJCC V8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Absolute change in the true diffusion coefficient (D)
timeFrame: Up to 3 months or 5 months (each cycle is 28 days)
Secondary outcomes:
measure: Diffusion related parameters in intravoxel incoherent motion diffusion weighted imaging
timeFrame: Up to 3 months or 5 months (each cycle is 28 days)
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Priya R Bhosale
role: PRINCIPAL_INVESTIGATOR
References: