MedTrace Logo

The Microbrect-FFC Study

NCT06236321 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-02-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Fast Field Cycling MRI scan

Three scans to be done over the period of cancer treatment

OTHER

Provision of saliva and faecal samples

Three times over the period of cancer treatment

Sponsors & Collaborators

  • University of Aberdeen

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-04
Primary Completion
2024-11-01
Completion
2024-11-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06236321 on ClinicalTrials.gov