NCT05876026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 8, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

May 16, 2023

Last Update Submit

January 6, 2026

Conditions

Rectal CancerLocally Advanced Rectal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People with rectal cancer (\>18 years of age) and no previous history of radiochemotherapy. The population will consist of people from the Region of Southern Denmark.

You may qualify if:

  • rectal cancer, age \>18 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vejle Hospital

Vejle, Jylland, 7100, Denmark

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Søren Rafaelsen, DMSc

    Vejle Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 25, 2023

Study Start

May 8, 2023

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations

DK(1)