Colorectal CancerNCT06236321
The Microbrect-FFC Study
A study testing Fast Field Cycling MRI scan and Provision of saliva and faecal samples in people with Colorectal Cancer, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Fast Field Cycling MRI scan and Provision of saliva and faecal samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Nov 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysing if Chemoradiotherapy Treatment in Rectal Cancer Can be Predicted by Fast Field Cycling Imaging and Microbiota Sampling. The Microbrect-FFC Study
This study will focus on two points:
- 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.
- 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.
Read more
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.
Read the detailed description
Sixty patients with locally advanced rectal cancer who require neoadjuvant chemoradiotherapy will be included. Patients will be identified at the Colorectal Cancer (CRC) Multidisciplinary Team (MDT) meeting when a diagnosis of rectal cancer is made. Patients will then meet the consultant to confirm the standard plan for treatment.
An out-patient appointment will be arranged for the patient to see a clinical oncologist. At this appointment the rationale, practical aspects and potential side effects of pre-operative therapy will be discussed. At this point the consultant will make the patient aware of the study. A written patient information sheet will be given to the patient to consider at home. Patients will be asked to contact a member of the team if they wish to take part.
If the participant agrees to take part written informed consent will obtained at their next hospital visit. Emphasis will be made to the patient that this study will not change the clinical management of their cancer. Pelvic radiotherapy is given as an out-patient. The first step is contouring the relevant anatomy, including tumour and associated lymph nodes, as well as normal organs that we want to limit the dose of radiation received. This contouring and preparation of a radiotherapy plan (for VMAT) can take up to two weeks so there is plenty of time for the first FFC scan and sampling to be done before treatment commences.
For patients who decide to enter the study, their first FFC imaging scan will be performed before starting the pelvic radiotherapy as an out-patient. The FFC imaging scans will take place in the PEDRI unit of the Biomedical Physics Building, Foresterhill, Aberdeen. All participants will complete an MRI safety screening form before having the scan. As for conventional clinical MRI scans, time and privacy will be given for the participants to change clothes and a safe will be provided to store their valuables during the scan. The scanning procedure will be explained to them before the scan, and they will be in audio contact with the scan controller for the duration of the scan. An alarm bell will be provided for them to signal any problems. The scan will be interrupted any time that a participant asks, and they will be able to stop the procedure and leave whenever they want to, without being asked for a reason.
The FFC imaging procedure will take up to 60 minutes and will include calibrations, navigator images and a T1 dispersion sequence, which will measure the T1 maps between 200 millitesla and 20 microtesla. After the scan, the participants will be given privacy to get dressed and will have access to the safe to collect their belongings. This scan will not delay the start of their clinical therapy and will occur in the two-week gap of radiotherapy planning required by the oncology team.
The oral sample will be collected in the radiotherapy department prior to the first NaT treatment, and the patient can choose to collect the faecal sample either at home or in the clinic, both on the day they are due to start the chemoradiotherapy. Sample kits will be provided to those who wish to collect their sample at home.
On the next visit, the patient will receive treatment as normal. On completion there will be a 7 to 8 week wait to allow the treatment to have an effect on the tumour, as well as allowing for any side effects to settle. After this gap, the patient will have their second FFC scan and will be asked to provide their second faecal and saliva sample. They will also have a pelvic MRI scan which will be reviewed at the Multi-Disciplinary Team, to assess if operation planes are now clear, allowing the patient to proceed to potentially curative surgery. Patients with a clear CRM will be asked to undertake their last FFC scan prior to surgery. During surgery a specimen will be collected from theatre and brought directly to the pathology department as per standard practice. The tumour itself will be assessed using a standardised approach, and any response graded using a validated and published system 6, 13. Patients who do not undergo surgery will be assumed to have a complete response and placed in this group for analysis
- Conditions
- Colorectal Cancer
- Being tested
- Fast Field Cycling MRI scan, Provision of saliva and faecal samples
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast Field Cycling MRI scanOther
Three scans to be done over the period of cancer treatment
Provision of saliva and faecal samplesOther
Three times over the period of cancer treatment
| Study group | Role | What they receive |
|---|---|---|
| Rectal cancer patients | Experimental | Patients with locally advanced rectal cancer who require neoadjuvant chemoradiotherapy Receives: Other: Fast Field Cycling MRI scan; Other: Provision of saliva and faecal samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
To determine acceptability of FFC imaging to patients with rectal cancer by analysing patient feedback
Completion of feedback questionnaire
Measured: 12 months
To determine correlation between faecal microbial composition and response to neoadjuvant chemoradiotherapy
We will undertake 16srRNA pyrosequencing of faecal samples from the patients who are having these FFC scans and correlate these analysis with reponse to treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start4 Nov 2022
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236321
- Sponsor's protocol ID
- 2-101-21
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysing if Chemoradiotherapy Treatment in Rectal Cancer Can be Predicted by Fast Field Cycling Imaging and Microbiota Sampling. The Microbrect-FFC Study
- ClinicalTrials.gov ID
- NCT06236321
- Acronym / sponsor ID
- 2-101-21
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will focus on two points:
- 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.
- 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.
Detailed description
Sixty patients with locally advanced rectal cancer who require neoadjuvant chemoradiotherapy will be included. Patients will be identified at the Colorectal Cancer (CRC) Multidisciplinary Team (MDT) meeting when a diagnosis of rectal cancer is made. Patients will then meet the consultant to confirm the standard plan for treatment.
An out-patient appointment will be arranged for the patient to see a clinical oncologist. At this appointment the rationale, practical aspects and potential side effects of pre-operative therapy will be discussed. At this point the consultant will make the patient aware of the study. A written patient information sheet will be given to the patient to consider at home. Patients will be asked to contact a member of the team if they wish to take part.
If the participant agrees to take part written informed consent will obtained at their next hospital visit. Emphasis will be made to the patient that this study will not change the clinical management of their cancer. Pelvic radiotherapy is given as an out-patient. The first step is contouring the relevant anatomy, including tumour and associated lymph nodes, as well as normal organs that we want to limit the dose of radiation received. This contouring and preparation of a radiotherapy plan (for VMAT) can take up to two weeks so there is plenty of time for the first FFC scan and sampling to be done before treatment commences.
For patients who decide to enter the study, their first FFC imaging scan will be performed before starting the pelvic radiotherapy as an out-patient. The FFC imaging scans will take place in the PEDRI unit of the Biomedical Physics Building, Foresterhill, Aberdeen. All participants will complete an MRI safety screening form before having the scan. As for conventional clinical MRI scans, time and privacy will be given for the participants to change clothes and a safe will be provided to store their valuables during the scan. The scanning procedure will be explained to them before the scan, and they will be in audio contact with the scan controller for the duration of the scan. An alarm bell will be provided for them to signal any problems. The scan will be interrupted any time that a participant asks, and they will be able to stop the procedure and leave whenever they want to, without being asked for a reason.
The FFC imaging procedure will take up to 60 minutes and will include calibrations, navigator images and a T1 dispersion sequence, which will measure the T1 maps between 200 millitesla and 20 microtesla. After the scan, the participants will be given privacy to get dressed and will have access to the safe to collect their belongings. This scan will not delay the start of their clinical therapy and will occur in the two-week gap of radiotherapy planning required by the oncology team.
The oral sample will be collected in the radiotherapy department prior to the first NaT treatment, and the patient can choose to collect the faecal sample either at home or in the clinic, both on the day they are due to start the chemoradiotherapy. Sample kits will be provided to those who wish to collect their sample at home.
On the next visit, the patient will receive treatment as normal. On completion there will be a 7 to 8 week wait to allow the treatment to have an effect on the tumour, as well as allowing for any side effects to settle. After this gap, the patient will have their second FFC scan and will be asked to provide their second faecal and saliva sample. They will also have a pelvic MRI scan which will be reviewed at the Multi-Disciplinary Team, to assess if operation planes are now clear, allowing the patient to proceed to potentially curative surgery. Patients with a clear CRM will be asked to undertake their last FFC scan prior to surgery. During surgery a specimen will be collected from theatre and brought directly to the pathology department as per standard practice. The tumour itself will be assessed using a standardised approach, and any response graded using a validated and published system 6, 13. Patients who do not undergo surgery will be assumed to have a complete response and placed in this group for analysis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal cancer patients | Experimental | Other: Fast Field Cycling MRI scan, Other: Provision of saliva and faecal samplesPatients with locally advanced rectal cancer who require neoadjuvant chemoradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast Field Cycling MRI scanThree scans to be done over the period of cancer treatment | Other | Rectal cancer patients |
| Provision of saliva and faecal samplesThree times over the period of cancer treatment | Other | Rectal cancer patients |
Primary outcome
To assess if subsets of Rectal Cancers can be correlated with FFC scan hydrogen ion dissociation curves
Time frame: 12 months
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.
2 secondary outcomes
To determine acceptability of FFC imaging to patients with rectal cancer by analysing patient feedback
Time frame: 12 months
To determine correlation between faecal microbial composition and response to neoadjuvant chemoradiotherapy
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast Field Cycling MRI scan and Provision of saliva and faecal samples in people with Colorectal Cancer, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess if subsets of Rectal Cancers can be correlated with FFC scan hydrogen ion dissociation curves (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.