MRI T1 Relaxation Time in Rectal Cancer

Recruiting

• Conditions: Rectal Cancer; Locally Advanced Rectal Carcinoma

• Registration Number: NCT05876026
• Lead Sponsor: Vejle Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-08
• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Vejle Hospital; 🇩🇰 Vejle, Jylland, Denmark