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MRI T1 Relaxation Time in Rectal Cancer

Sponsor
Vejle Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05876026
Collaborator
(none)
108
Enrollment
1
Location
31.8
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    108 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    MRI T1 Relaxation Times in Evaluating Neoadjuvant Treatment of Rectal Cancer
    Actual Study Start Date :
    May 8, 2023
    Anticipated Primary Completion Date :
    Jul 30, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Difference in T1 relaxation time (ms) in the rectal cancer tumor measured in IntelliSpace-software before and after neoadjuvant radiochemotherapy. [6 to 8 weeks.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vejle Hospital Vejle Jylland Denmark 7100

    Sponsors and Collaborators

    • Vejle Hospital

    Investigators

    • Study Chair: Søren Rafaelsen, DMSc, Vejle Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vejle Hospital
    ClinicalTrials.gov Identifier:
    NCT05876026
    Other Study ID Numbers:
    • T1 relaxation MRI
    First Posted:
    May 25, 2023
    Last Update Posted:
    May 25, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of May 25, 2023