An Investigational Scan (MR DENSE) in Detecting Early Chemotherapy-Related Liver Injury Before Surgery in Patients With Resectable Colorectal Liver Metastases
Primary Purpose
Colorectal Carcinoma Metastatic in the Liver
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Imaging
Magnetic Resonance Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Carcinoma Metastatic in the Liver
Eligibility Criteria
Inclusion Criteria:
- Patients treated with neoadjuvant chemotherapy and scheduled for hepatectomy, per standard of care at our institution, and meet criteria for hepatectomy.
- No contraindications to MRI (such implanted ferromagnetic or pump devices, metallic fragments in eye), as indicated on our departmental MRI screening form.
- Patient who is able to undergo informed consent.
- Men and non-pregnant women.
- Metastatic disease limited to liver.
- Metastases involving no more than 6 liver segments.
- No radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes.
Exclusion Criteria:
- Contraindication to MRI.
- Inability to comply with study and/or follow-up procedures.
- Unable to provide informed consent.
- Presence of extrahepatic metastatic disease.
- Metastases involving more than 6 liver segments.
- Radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes.
- Pregnant women.
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (standard of care MRI, MR DENSE MRI)
Arm Description
Patients undergo standard of care MRI and then undergo an MRI of the liver using MR DENSE imaging sequences over 60-90 minutes. Healthy volunteers undergo MRI of the liver using DENSE imaging sequences.
Outcomes
Primary Outcome Measures
Magnetic Resonance Displacement Encoding with Stimulated Echo (MR DENSE) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury.
Secondary Outcome Measures
Full Information
NCT ID
NCT05059717
First Posted
September 9, 2021
Last Updated
November 10, 2021
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05059717
Brief Title
An Investigational Scan (MR DENSE) in Detecting Early Chemotherapy-Related Liver Injury Before Surgery in Patients With Resectable Colorectal Liver Metastases
Official Title
Imaging Tissue Motion Using MR Displacement Encoding With Stimulated Echo (DENSE): Detection of Early Chemotherapy Related Liver Injury Prior to Resection of Colorectal Liver Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial studies how well a magnetic resonance imaging technique called Displacement Encoding with Stimulated Echo (DENSE) works in detecting chemotherapy-related liver injury in patients with colorectal cancer that has spread to the liver and can be removed by surgery. Researchers want to learn if the DENSE technique improves the standard MRI method.
Detailed Description
PRIMARY OBJECTIVE:
I. This is an exploratory study to collect Magnetic Resonance Displacement Encoding with Stimulated Echo (MR DENSE) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury.
SECONDARY OBJECTIVES:
I. Estimate sensitivity of MR DENSE (determine degree of 2 dimensional [2D] vector displacement with cardiac cycle and variability of measurements with cardiac ventricle contraction).
II. Determine detection of sinusoidal injury (sinusoidal fibrosis, necrosis of pericentral hepatocytes, narrowing and fibrosis of central veins) on biopsy with non-alignment of 2D point vectors (horizontal and vertical direction) from neighboring/immediate adjacent points on MR DENSE imaging.
III. Determine correlation of intra-operative surgical scores (liver color and texture) with non-alignment of 2D point vectors (horizontal and vertical direction) from neighboring/immediate adjacent points on MR DENSE imaging.
OUTLINE:
Patients undergo standard of care magnetic resonance imaging (MRI) and then undergo an MRI of the liver using MR DENSE imaging sequences over 60-90 minutes. Healthy volunteers undergo MRI of the liver using DENSE imaging sequences.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma Metastatic in the Liver
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (standard of care MRI, MR DENSE MRI)
Arm Type
Experimental
Arm Description
Patients undergo standard of care MRI and then undergo an MRI of the liver using MR DENSE imaging sequences over 60-90 minutes. Healthy volunteers undergo MRI of the liver using DENSE imaging sequences.
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo standard of care MRI
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MR DENSE imaging
Primary Outcome Measure Information:
Title
Magnetic Resonance Displacement Encoding with Stimulated Echo (MR DENSE) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury.
Time Frame
through study completion, an average of a year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients treated with neoadjuvant chemotherapy and scheduled for hepatectomy, per standard of care at our institution, and meet criteria for hepatectomy.
No contraindications to MRI (such implanted ferromagnetic or pump devices, metallic fragments in eye), as indicated on our departmental MRI screening form.
Patient who is able to undergo informed consent.
Men and non-pregnant women.
Metastatic disease limited to liver.
Metastases involving no more than 6 liver segments.
No radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes.
Exclusion Criteria:
Contraindication to MRI.
Inability to comply with study and/or follow-up procedures.
Unable to provide informed consent.
Presence of extrahepatic metastatic disease.
Metastases involving more than 6 liver segments.
Radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes.
Pregnant women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priya Bhosale
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://mdanderson.org
Description
M D Anderson Cancer Center
Learn more about this trial
An Investigational Scan (MR DENSE) in Detecting Early Chemotherapy-Related Liver Injury Before Surgery in Patients With Resectable Colorectal Liver Metastases
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