The Microbrect-FFC Study

NCT06236321 | Unknown

• 1 other identifier: 2-101-21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will focus on two points:

1. 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. 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• To assess if subsets of Rectal Cancers can be correlated with FFC scan hydrogen ion dissociation curves

  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.

  12 months

Secondary Outcomes (2)

• To determine acceptability of FFC imaging to patients with rectal cancer by analysing patient feedback

  12 months

• To determine correlation between faecal microbial composition and response to neoadjuvant chemoradiotherapy

  12 months

Study Arms (1)

Rectal cancer patients

EXPERIMENTAL

Patients with locally advanced rectal cancer who require neoadjuvant chemoradiotherapy

Other: Fast Field Cycling MRI scan; Other: Provision of saliva and faecal samples

Interventions

Fast Field Cycling MRI scan OTHER

Three scans to be done over the period of cancer treatment

Rectal cancer patients

Provision of saliva and faecal samples OTHER

Three times over the period of cancer treatment

Rectal cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

University of Aberdeen

Aberdeen, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

George Ramsay

CONTACT

07846663356; george.ramsay@abdn.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: February 1, 2024
• Study Start: November 4, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 1, 2024

Record last verified: 2023-08

Locations

GB (1)