Study Stopped
Study did not meet enrollment goals.
Metastatic Colorectal Cancer: Treatment Response With Dynamic Contrast MRI
Angle Interleaved Projection Reconstruction With K-Space Weighted Image Reconstruction for Dynamic Contrast MRI of Cancer Therapy Response
2 other identifiers
observational
6
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2008
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 9, 2009
CompletedFirst Posted
Study publicly available on registry
January 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2009
CompletedAugust 1, 2023
July 1, 2023
1.8 years
January 9, 2009
July 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To determine the reproducibility of DCE-MRI measures of tumor Ktrans, kep, and ve for colorectal metastases to the liver (Arm A) and any cancer metastatic to the liver (Arm B), using projection interleaved back-projection DCE-MRI techniques.
Three (3) DCE-MRI scans (two separate pre-treatment and one post-treatment DCE-MRI exams [post-treatment defined as after the first cycle of chemotherapy with bevacizumab])
To determine the alteration in tumor vascularity (assessed by percentage change in tumor Ktrans) in Arm A participants with metastatic colorectal cancer to the liver after one cycle of chemotherapy including bevacizumab compared to baseline Ktrans value.
Two (2) DCE-MRI scans (baseline pre-treatment and post-treatment DCE-MRI exams [post-treatment defined as after the first cycle of chemotherapy with bevacizumab])
Secondary Outcomes (4)
To determine the relationship between initial tumor vascularity (absolute tumor Ktrans) and change in tumor vascularity (percentage change in tumor Ktrans after one cycle of chemotherapy) and PFS in participants in Arm A.
Two (2) DCE-MRI scans (baseline pre-treatment and post-treatment DCE-MRI exams [post-treatment defined as after the first cycle of chemotherapy with bevacizumab]) with follow-up
To evaluate the perfusional difference between the dominant tumor and the global tumor burden (Arms A and B).
Three (3) DCE-MRI scans (two separate pre-treatment and one post-treatment DCE-MRI exams [post-treatment defined as after the first cycle of chemotherapy with bevacizumab])
To evaluate the feasibility of exporting back-projection DCE-MRI imaging across multiple MRI scanner vendor platforms for use in a multi-site chemotherapy trial.
Three (3) DCE-MRI scans (two separate pre-treatment and one post-treatment DCE-MRI exams [post-treatment defined as after the first cycle of chemotherapy with bevacizumab])
To determine the functional status as a predictor of response or disease-free survival in participants in Arm A.
Three (3) DCE-MRI scans (two separate pre-treatment and one post-treatment DCE-MRI exams [post-treatment defined as after the first cycle of chemotherapy with bevacizumab]) with follow-up for response and disease-free survival
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
At each participating site, at least one oncologist treating patients with adenocarcinoma of the colon and rectum must agree to serve as a co-investigator on the study. However, all oncologists directly or indirectly affiliated with the participating institution may serve as a source of participants for this trial. Patients with adenocarcinoma of the colon or rectum metastatic to the liver who are present candidates for FOLFOX plus bevacizumab are eligible to enroll in this imaging trial in Arm A. Patients with any primary carcinoma with metastatic disease to the liver who are in stable treatment condition prior to and between scnas are eligible to enroll in this imaging trial in Arm B.
You may qualify if:
- 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);
- +13 more criteria
You may not qualify if:
- Patients with contraindication to MRI, including:
- Contraindicated metallic device, including pacemaker, non-MRI compatible aneurysm clip, other non-MRI compatible mechanical and/or electrical device, or metallic fragments;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American College of Radiologylead
- Pennsylvania Department of Healthcollaborator
Study Sites (5)
Penn State University Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19017, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Rosen, MD, PhD
University of Pennsylvania
- STUDY CHAIR
Larry Dougherty, PhD
University of Pennsylvania
- STUDY CHAIR
Donald Mitchell, MD
Thomas Jefferson University
- STUDY CHAIR
Peter J O'Dwyer, MD
University of Pennsylvania
- STUDY CHAIR
Michael D Feldman, MD, PhD
University of Pennsylvania
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2009
First Posted
January 12, 2009
Study Start
April 1, 2008
Primary Completion
December 31, 2009
Study Completion
December 31, 2009
Last Updated
August 1, 2023
Record last verified: 2023-07