Metastatic Colorectal Cancer: Treatment Response With Dynamic Contrast MRI

NCT ID: NCT00820456

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-12-31

Brief Summary

The objectives for this study include:

• Testing a unique way of imaging people with colorectal cancer and other cancers that has spread to the liver using magnetic resonance imaging (MRI);
• Seeing if the MRI process can be used across multiple imaging platforms;
• Determining whether the results of the imaging can be reproduced;
• Reviewing how MRI results relate to cancer response to combination therapy and to clinical endpoints.

Detailed Description

This study will investigate the use of projection reconstruction dynamic contrast-enhanced MRI (DCE-MRI) as a surrogate marker of tumor vascularity in patients treated with the antiangiogenic agent bevacizumab. DCE-MRI is gaining popularity as a method to assess the functional response of tumors to agents targeting the vascular endothelial growth factor (VGEF) pathways. DCE-MRI measurements have been proposed as a non-invasive measure of both tumor biologic activity and (in the case of antivascular therapy) early response to treatment. A number of phase I and II studies demonstrate the ability for DCE-MRI to detect perfusion changes associated with tumor biologic response to vascularly targeted agents. It has been suggested that pre-treatment DCE-MRI might identify tumors with high intrinsic perfusion and that these tumors will be more likely to respond to antivascular-based therapies. However, the current use of DCE-MRI in clinical settings is challenging. Trade-offs between spatial coverage, time, and spatial resolution make this technique difficult to implement in human studies and may limit its reliability. The use of projection reconstruction-based acquisition can mitigate the need for these trade-offs and can simultaneously provide high temporal and spatial resolution data for DCE-MRI analysis.

Conditions

Colorectal Neoplasm; Hepatic Neoplasm

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Colorectal Cancer, Hepatic Metastasis

Eligible participants in Arm A enrolled in this imaging study will: be older than 18, have metastatic colorectal cancer with at least one hepatic lesion, and be treated with FOLFOX in combination with bevacizumab.

DCE-MRI

Intervention Type: OTHER

Participants will receive two (2) dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) prior to chemotherapy and one (1) DCE-MRI after the first cycle of chemotherapy. Participants will be followed for up to 2 years after the initiation of chemotherapy or until disease progression.

Primary Tumor Undefined, Hepatic Metastasis

Eligible participants in Arm B enrolled in this imaging study will: be older than 18, must have prior histological documentation of any types of cancer with metastasis to the liver, and must be in stable treatment conditions prior to and between scans.

DCE-MRI

Intervention Type: OTHER

Participants will receive two (2) dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) prior to chemotherapy and one (1) DCE-MRI after the first cycle of chemotherapy. Participants will be followed for up to 2 years after the initiation of chemotherapy or until disease progression.

Interventions

DCE-MRI

Participants will receive two (2) dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) prior to chemotherapy and one (1) DCE-MRI after the first cycle of chemotherapy. Participants will be followed for up to 2 years after the initiation of chemotherapy or until disease progression.

Intervention Type: OTHER

Other Intervention Names

Dynamic Contrast Enhanced Magnetic Resonance Imaging; dynamic contrast MRI; perfusion MRI; perfusion imaging

Eligibility Criteria

Inclusion Criteria

• Participants must be >18 years old;
• Participants must have an ECOG performance status of 0-1;
• Participants must not be pregnant or breastfeeding;
• Participants must have prior histological documentation of adenocarcinoma of the colon or rectum;
• Participants must be commencing chemotherapy with FOLFOX plus bevacizumab;
• Participants must not have had prior exposure to bevacizumab. Prior systemic chemotherapy with other agents is allowed. The last dose of systemic chemotherapy must have been > 3 months prior to study entry;
• Participants with prior radiotherapy or other prior local therapy to the liver (radioablation therapy, chemoembolic therapy) are acceptable. They must be at least 4 weeks past the last administration of such therapy;
• Participants must be at least 4 weeks past any major surgery, including surgery to the liver;
• Participants with prior malignancies other than colon cancer are allowed, provided they have been treated with curative intent, and have no evidence of recurrence of that malignancy;
• Participants must have a life expectancy of greater than 3 months;
• Participants must have the ability to understand and the willingness to sign a written informed consent form.

• Participants must be >18 years old;
• Participants must have an ECOG performance status of 0-1;
• Participants must not be pregnant or breastfeeding;
• Participants must have prior histological documentation of any types of cancer with metastasis to the liver (see Imaging Criteria below);
• Participants must be projected to be within a stable treatment condition prior to and between scans (see section 4.3 for definition of stable treatment condition);
• Participants must be at least 4 weeks past any major surgery, including surgery to the liver;
• Participants must have a life expectancy of greater than 3 months;
• Participants must have the ability to understand and the willingness to sign a written informed consent form.

Imaging Criteria:

• Participants must have at least one hepatic lesion greater than or equal to 3 cm in maximal diameter on cross sectional imaging study (CT or MRI) performed within 4 weeks prior to study enrollment;
• Participants must have at least one qualifying liver lesion (i.e. one greater than or equal to 3 cm) that has been confirmed metastatic adenocarcinoma of the colon or rectum based on one of the following criteria:

• Histologic (FNA or core biopsy) proof of malignancy compatible with metastasis from a colorectal carcinoma; OR
• Demonstration of imaging features of tumor metastasis to the liver, including at least one of the following:

1. evidence of heterogeneous enhancement or central tumor necrosis by CT or MRI;

2. previously demonstrated interval enlargement of the lesion by >25% in the longest diameter;

3. PET image demonstrating metabolic activity characteristic of malignancy (FDG uptake greater than that of background liver).

• For participants who have undergone local hepatic surgical, radiation, ablative, or embolic therapy, the date of qualifying imaging study(ies) or qualifying biopsy must be at least 30 days after the last instance of such local therapy. Furthermore, cross-sectional imaging performed at least 30 days after such local therapy must demonstrate an area of residual viable tumor (as judged by enhancing tissue following contrast administration) with longest diameter ≥ 3cm in at least one cross-sectional axis.

Exclusion Criteria

• Patients with contraindication to MRI, including:

1. Contraindicated metallic device, including pacemaker, non-MRI compatible aneurysm clip, other non-MRI compatible mechanical and/or electrical device, or metallic fragments;

2. Patients with severe claustrophobia (patients with milder forms of claustrophobia that can be successfully allayed with oral anxiolytic therapy are allowed);

• Patients with contraindication to gadolinium, including:

a) Hypersensitivity to gadolinium-containing MR contrast agents;

• Severe impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73 m2 and/or on dialysis;
• Patients with severely compromised pulmonary, cardiovascular, or mental status. Patients must not have severe congestive heart failure (defined as New York Heart Association Class II or greater);
• For Arm A only: Any other major medical illness that, in the investigator's opinion, would: (1) prevent administration or completion of institution's standard of care FOLFOX/bevacizumab therapy; (2) prevent administration or completion of protocol-specified imaging; and/or (3) interfere with follow-up.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pennsylvania Department of Health

OTHER_GOV

Sponsor Role: collaborator

American College of Radiology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Rosen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Larry Dougherty, PhD

Role: STUDY_CHAIR

University of Pennsylvania

Donald Mitchell, MD

Role: STUDY_CHAIR

Thomas Jefferson University

Peter J O'Dwyer, MD

Role: STUDY_CHAIR

University of Pennsylvania

Michael D Feldman, MD, PhD

Role: STUDY_CHAIR

University of Pennsylvania

Locations

Penn State University Hershey Medical Center

Hershey, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

SAP #4100031303

Identifier Type: -

Identifier Source: secondary_id

ACRIN PA 4002

Identifier Type: -

Identifier Source: org_study_id