Clinical trial · Interventional
The Microbrect-FFC Study
Analysing if Chemoradiotherapy Treatment in Rectal Cancer Can be Predicted by Fast Field Cycling Imaging and Microbiota Sampling. The Microbrect-FFC Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fast Field Cycling MRI scan | Other | — | UNRESOLVED |
| Provision of saliva and faecal samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rectal cancer patients
- description
- Patients with locally advanced rectal cancer who require neoadjuvant chemoradiotherapy
- interventionNames
- Other: Fast Field Cycling MRI scan
- Other: Provision of saliva and faecal samples
Primary outcomes (1)
- measure
- To assess if subsets of Rectal Cancers can be correlated with FFC scan hydrogen ion dissociation curves
- timeFrame
- 12 months
- description
- We will analyse hydrogen ion relaxation curves and correlate these curves with response to neoadjuvant chemoradiotherapy. Response has been standardised into Complete, Good partial, partial and minimal and these have been validated in previous studies. We will assess whether changes in hydrogen ion relaxation curves between rectal cancer patients can link with these response categories.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must be aged 18 and above * Patients with locally invasive rectal adenocarcinoma cancer clinically requiring neoadjuvant chemoradiotherapy * Participants who meet the safety criteria for undergoing an MRI scan. * Participants who can pass through a 50 cm-diameter circular hoop to ensure they will be able to fit inside the scanner * Participants must be able to give fully informed consent. * Participants must be mobile enough to be positioned onto the FFC scanner couch. * Patients willing to provide faecal and saliva samples on two occasions Exclusion Criteria: * MRI-incompatible conditions, as detected in the MRI safety screening sheet * Patients with early rectal cancers * Patients with squamous cell cancers * Patients with colon cancers * Patients presenting as an emergency with an obstructing rectal cancer * Patients who are treated with short course radiotherapy alone rather than long course chemoradiotherapy * Participants under 18 years old. * Participants who are unable to communicate in English. * Participants who are unable to give fully informed consent. * Women who are pregnant. * Restrictions to mobility that would prevent the correct positioning in the scanner. * Patients who suffer from claustrophobia.
References
Publications (0)
Data not yet available