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NCT05876026 Clinical Trial

MRI T1 Relaxation Time in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:
MRI T1 Relaxation Times in Evaluating Neoadjuvant Treatment of Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05876026
Other study ID # T1 relaxation MRI
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 8, 2023
Est. completion date December 31, 2025

Study information
Verified date May 2024
Source Vejle Hospital
Contact Mathias Byriel
Phone 004525658865
Email mathias.rosenfeldt.byriel@rsyd.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to learn about the T1 relaxation time and T1 relaxation time properties of the disease in people with locally advanced rectal cancer. The main question it aims to answer is: Does MRI T1 relaxation time have a high diagnostic performance in recognizing fibrosis as a complete response to neoadjuvant treatment of rectal cancer? Participants will receive standard neoadjuvant treatment and be part of the standard examination programme regarding rectal cancer.

Recruitment information / eligibility
Status Recruiting
Enrollment 108
Est. completion date December 31, 2025
Est. primary completion date July 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - rectal cancer, age >18 years Exclusion Criteria: - contraindications for MRI (pacemaker, claustrophobia, implanted medical injectors and nerve stimulators), - previous radiochemotherapy or another disease which investigator judges inappropriate for the persons continued participation.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Vejle Hospital Vejle Jylland

Sponsors (1)
Lead Sponsor Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in T1 relaxation time (ms) in the rectal cancer tumor measured in IntelliSpace-software before and after neoadjuvant radiochemotherapy. An MRI T1 relaxation time-map is performed on each participant. The data is transferred to IntelliSpace-software for measurement and mapping. It is measured in miliseconds (ms) before and after neoadjuvant treatment. 6 to 8 weeks.
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