An Investigational Scan (MR DENSE) in Detecting Early Chemotherapy-Related Liver Injury Before Surgery in Patients With Resectable Colorectal Liver Metastases

NCT05059717 | Withdrawn

• 2 other identifiers: 2016-1115NCI-2019-02483
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Carcinoma Metastatic in the Liver

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of a year.

Study Arms (1)

Diagnostic (standard of care MRI, MR DENSE MRI)

EXPERIMENTAL

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.

Procedure: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging PROCEDURE

Undergo standard of care MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Diagnostic (standard of care MRI, MR DENSE MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Priya Bhosale

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 28, 2021
• Study Start: July 12, 2018
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: November 13, 2023

Record last verified: 2023-11