NCT06236321

The Microbrect-FFC Study

Status unknown NA Last updated 1 February 2024

What this trial tests

NA trial testing Fast Field Cycling MRI scan in Colorectal Cancer in 60 participants. Status unknown.

Timeline

4 November 2022

Primary endpoint
1 November 2024

1 November 2024

Quick facts

Lead sponsor	University of Aberdeen
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	60
Start date	4 November 2022
Primary completion	1 November 2024
Estimated completion	1 November 2024
Sites	1 location across United Kingdom

Drugs / interventions tested

• Fast Field Cycling MRI scan
• Provision of saliva and faecal samples

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

University of Aberdeen

Who can join

18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will focus on two points:

1. To determine if response to neoadjuvant chemoradiotherapy treatment in rectal cancer can be predicted by analysing data from Fast Field Cycling imaging (FFC), a novel type of MRI technique.
2. To determine if there is evidence that the bacteria living in our mouth and in our large bowel influence the way our body responds to cancer treatment.

Rectal cancer which is locally advanced is often managed with pre-operative chemoradiotherapy. The idea is to reduce the size of the cancer and increase the chance of a complete resection at the time of an operation. Interestingly, in approximately 20% of patients a complete response (with no evidence of residual tumour) occurs. As yet, there is no mechanism to predict for complete response before treatment. In this study we seek to assess whether FFC or the microbiota can correlate with response.

In this study 60 patients with rectal cancer requiring chemoradiotherapy before surgery will be asked to take part. Each patient will have up to three FFC scans. One scan will be done prior to commencement of neoadjuvant chemoradiotherapy, the second will be arranged for seven to eight weeks after the patient has completed the preoperative treatment and the third will be done before any subsequent surgery (if required). Participants will also be asked to give saliva and bowel motions samples before chemoradiotherapy, and after eight weeks. These samples will have the type and number of bacteria analysed, as well as levels of key products of these bacteria.

The FFC imaging scans and the microbiota of the saliva and faecal samples will be analysed and results compared to the response to chemoradiotherapy using standard criteria agreed upon at the regional colorectal cancer Multidisciplinary clinical team meeting.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.