The Microbrect-FFC Study

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Participants enrolled: 15
• From 4 Nov 2022 to the primary completion date, 31 May 2024
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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