Predicting treatment response in rectal cancer using advanced MRI and microbiome analysis

Analysing if Chemoradiotherapy Treatment in Rectal Cancer Can be Predicted by Fast Field Cycling Imaging and Microbiota Sampling. The Microbrect-FFC Study

This study is testing if special MRI scans and analysis of gut bacteria can help predict how well patients with advanced rectal cancer will respond to their treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Aberdeen (other)
• Drugs / interventions: radiation
• Locations: 1 site (Aberdeen)
• Trial ID: NCT06236321 on ClinicalTrials.gov

What this trial studies

This study aims to determine if the response to neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer can be predicted through Fast Field Cycling (FFC) MRI imaging and analysis of oral and gut microbiota. Sixty patients requiring this treatment will undergo FFC scans and provide saliva and fecal samples to assess correlations with treatment outcomes. The study will not alter the standard clinical management of the patients' cancer but seeks to enhance predictive capabilities for treatment response. Participants will be recruited through a multidisciplinary team meeting and will provide informed consent before participation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and above with locally invasive rectal adenocarcinoma requiring neoadjuvant chemoradiotherapy.

Not a fit: Patients with early rectal cancers, squamous cell cancers, or those requiring emergency treatment for obstructing rectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prediction of treatment responses in rectal cancer, allowing for more personalized treatment plans.

How similar studies have performed: While the use of FFC MRI is novel, studies exploring the relationship between microbiota and treatment responses in cancer are emerging, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Aberdeen

• University of Aberdeen — Aberdeen, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: George Ramsay

Conditions: Colorectal Cancer