Colorectal Cancer (CRC)AIR-RECNCT06822634
Advances in Imaging to Assess Response in Rectal Cancer
An observational study of Colorectal Cancer (CRC), run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to determine the feasibility of acquiring serial MRI images for advanced radiotherapy planning in colorectal patients. The main question it aims to answer: Is it feasible to acquire serial MR images for advanced radiotherapy planning for rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- Observational single centre feasibility study
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2024to 26 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population will be locally advanced rectal cancer patients with histologically confirmed rectal adenocarcinoma. 20 patients will be recruited to the study.
Who may be able to join
- Histologically confirmed rectal adenocarcinoma.
- T stage 3b or above and/or high risk factors eg. EMVI, nodal disease.
- Participant able to give written informed consent.
- Male or non-pregnant female ≥18 years of age.
- Scheduled to undergo radical radiotherapy.
- Patients willing and able to comply with the protocol for the duration of study.
Who cannot join
- Contra-indications to MRI, such as claustrophobia, excessive body weight, MRI unsafe implants, ferrous metal in the body, insufficient information on prior surgeries. MRI conditional implants where conditions cannot be met (e.g pacemakers).
- Any previous radiotherapy to the pelvis.
- Inflammatory bowel disease.
- Other severe or uncontrolled systemic disease or evidence of any other significant disorder or lab finding that makes it undesirable for the patient to participate in the study, as determined by the treating clinician.
- History of physical or psychiatric disorder that would prevent informed consent and compliance with the protocol.
- Patients with de-functioning stoma.
- Major surgery within 28 days prior to trial entry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, G120YN
Ms Lynsey Devlin, 0141 301 9902, lynsey.devlin@nhs.scot
Ms Aileen Duffton, PhD Cancer sciences, 0141 301 7428, aileen.duffton@nhs.scot
About this study
Official title: Advances in Imaging to Assess Response in Rectal Cancer (AIR-REC)
The goal of this observational study is to determine the feasibility of acquiring serial MRI images for advanced radiotherapy planning in colorectal patients.
The main question it aims to answer:
Is it feasible to acquire serial MR images for advanced radiotherapy planning for rectal cancer.
Read the detailed description
Bowel cancer is the 4th most common cancer in the UK and accounts for 11% of all new cancer diagnoses, a third of these cancers are located in the rectum. Approximately 732, 000 rectal cancers are diagnosed in Europe per year.
Radiotherapy (RT) is a well-established treatment for locally advanced rectal cancer (LARC). It can be used pre operatively in margin threatening disease to increase the likelihood of R0 resection margins; reduce the rate of loco regional recurrence; and to improve loco regional control for patients unsuitable for surgery. There are two treatment regimes used internationally, with strong evidence from numerous randomised clinical trials. These are long course chemoradiotherpy (LCRT) with a dose of 45-60Gy delivered in 25 fractions and short course radiotherapy (SCRT) with a dose of 25Gy in 5 fractions. No long-term superiority of either approach has been found thus far.
RT indications for LARC are defined by clinic-radiological MRI defined criteria. Accurate and precise delineation of the target volume is fundamental to the success of RT. CT planning scans are traditionally used for target delineation in RT, have poor soft tissue contrast and on this dataset have shown overestimation of tumour volumes. Given that magnetic resonance images (MRI) brings superior visualisation of soft tissue in the diagnostic phase of LARC, there has been a move towards routine use of MRI within the delivery of RT.
MRI imaging is considered the gold standard in the staging and response assessment of rectal cancers. The rectum lends well to the exquisite soft tissue definition MRI offers, and additional functional information can be used to further characterise tumour. Improved tumour localisation up front and assessment of responses during RT has the potential to improve patient outcomes in numerous ways.
The use of MRI in RT planning of rectal cancer is relatively new. A survey of UK practice identified specifically 64% of centres use a diagnostic MRI alongside to aid delineation, 28% register MRI images with the diagnostic scan and only 3% use a registered scan in the RT position. National rectal cancer guidelines recommend MRI to be used if possible to aid delineation of the gross tumour volume (GTV). A report published by IPEM gives clear guidance for the optimal use in RT planning for rectal cancer.
There is a general acceptance that the use of MRI in rectal cancer RT planning is superior. In the literature there are a number of studies looking at different aspects of MRI application in the rectal cancer RT pathway. However, there is great disparity in the focus of these research papers.
One of the main challenges in gaining optimal benefit from this technology is the many uncertainties in the planning and delivery of RT to rectal cancers. Largely due to the target being a soft tissue structure, which moves independently due to gas and faecal filling. The surrounding elective volume includes the mesorectum and regional lymph nodes, resulting in targets with a differential motion. This brings more uncertainty in reproducibility, the foundation of accurate and precise RT. MRI with improved soft tissue visualisation could potentially enable voluming of only the tumour and not the full rectal lumen. This could be practice changing and requires careful consideration in implementation. For these reasons correct application of MRI in rectal cancer RT planning is crucial to ensure the optimal benefit from this technology is gained. In the setting of serial imaging reproducibility is more important, where repeatability and reliability of data matters more.
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- Observational single centre feasibility study
- Keywords
- Colorectal cancer, colorectal cancer (crc), CRC, MRI
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational single centre feasibility studyOther
Patients scheduled to undergo standard of care neo. adjuvant radiotherapy prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer patients | Patients with histologically confirmed invasive rectal adenocarcinoma Receives: Other: Observational single centre feasibility study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of acquiring serial MRI for advanced radiotherapy planning of rectal cancer.
Feasibility defined as 70% of study participants completing a baseline and repeat scan acquisition.
Measured: 18 months
Secondary outcomes (4)
Volumetric radiotherapy target volume data- longitudinal changes in radiotherapy target volume data measured in cubic centimetres
Identify anatomical changes in radiotherapy target volume from baseline and repeat scans measured in cubic centimetres.
Measured: 18 Months
Quantification of MR image parameters- extraction of apparent diffusion coefficient (ADC) from defined radiotherapy target volumes on functional MR images
Feasibility of measuring apparent diffusion coefficient (ADC) using functional MR sequences on baseline and repeat scans, defined as a quantified value in mm²/s (square millimetres per second).
Measured: 18 months
Quantify inter-observer target delineations
Quantify inter-observer variation in target delineations on CT and MRI sequences.
Record inter observer agreement metrics and volume between observers on CT and MRI datasets.
Measured: 18 months
Health-related quality of life of study participant using European Organisation for Research and Treatment of Cancer patients' validated tools EORTC QLQ CR30 and EORTC CR 29
To measure health related quality of life of study participants validated tools EORTC QLQ CR30 and EORTC CR 29.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start11 Nov 2024
- Primary completion26 Jun 2026 (estimated)
- Study completion26 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ms Lynsey Devlin, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822634
- Sponsor's protocol ID
- GN23ON218
- Other IDs
- 329328
- Acronym
- AIR-REC
- Status last verified
- Feb 2025
- First submitted
- 14 Jan 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advances in Imaging to Assess Response in Rectal Cancer (AIR-REC)
- ClinicalTrials.gov ID
- NCT06822634
- Acronym / sponsor ID
- AIR-REC / GN23ON218
- Conditions
- Colorectal Cancer (CRC)
- Keywords
- Colorectal cancer, colorectal cancer (crc), CRC, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 26 Jun 2026 (estimated)
- Study completion
- 26 Jun 2026 (estimated)
- First posted
- 12 Feb 2025 (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.
The goal of this observational study is to determine the feasibility of acquiring serial MRI images for advanced radiotherapy planning in colorectal patients.
The main question it aims to answer:
Is it feasible to acquire serial MR images for advanced radiotherapy planning for rectal cancer.
Detailed description
Bowel cancer is the 4th most common cancer in the UK and accounts for 11% of all new cancer diagnoses, a third of these cancers are located in the rectum. Approximately 732, 000 rectal cancers are diagnosed in Europe per year.
Radiotherapy (RT) is a well-established treatment for locally advanced rectal cancer (LARC). It can be used pre operatively in margin threatening disease to increase the likelihood of R0 resection margins; reduce the rate of loco regional recurrence; and to improve loco regional control for patients unsuitable for surgery. There are two treatment regimes used internationally, with strong evidence from numerous randomised clinical trials. These are long course chemoradiotherpy (LCRT) with a dose of 45-60Gy delivered in 25 fractions and short course radiotherapy (SCRT) with a dose of 25Gy in 5 fractions. No long-term superiority of either approach has been found thus far.
RT indications for LARC are defined by clinic-radiological MRI defined criteria. Accurate and precise delineation of the target volume is fundamental to the success of RT. CT planning scans are traditionally used for target delineation in RT, have poor soft tissue contrast and on this dataset have shown overestimation of tumour volumes. Given that magnetic resonance images (MRI) brings superior visualisation of soft tissue in the diagnostic phase of LARC, there has been a move towards routine use of MRI within the delivery of RT.
MRI imaging is considered the gold standard in the staging and response assessment of rectal cancers. The rectum lends well to the exquisite soft tissue definition MRI offers, and additional functional information can be used to further characterise tumour. Improved tumour localisation up front and assessment of responses during RT has the potential to improve patient outcomes in numerous ways.
The use of MRI in RT planning of rectal cancer is relatively new. A survey of UK practice identified specifically 64% of centres use a diagnostic MRI alongside to aid delineation, 28% register MRI images with the diagnostic scan and only 3% use a registered scan in the RT position. National rectal cancer guidelines recommend MRI to be used if possible to aid delineation of the gross tumour volume (GTV). A report published by IPEM gives clear guidance for the optimal use in RT planning for rectal cancer.
There is a general acceptance that the use of MRI in rectal cancer RT planning is superior. In the literature there are a number of studies looking at different aspects of MRI application in the rectal cancer RT pathway. However, there is great disparity in the focus of these research papers.
One of the main challenges in gaining optimal benefit from this technology is the many uncertainties in the planning and delivery of RT to rectal cancers. Largely due to the target being a soft tissue structure, which moves independently due to gas and faecal filling. The surrounding elective volume includes the mesorectum and regional lymph nodes, resulting in targets with a differential motion. This brings more uncertainty in reproducibility, the foundation of accurate and precise RT. MRI with improved soft tissue visualisation could potentially enable voluming of only the tumour and not the full rectal lumen. This could be practice changing and requires careful consideration in implementation. For these reasons correct application of MRI in rectal cancer RT planning is crucial to ensure the optimal benefit from this technology is gained. In the setting of serial imaging reproducibility is more important, where repeatability and reliability of data matters more.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer patients | – | Other: Observational single centre feasibility studyPatients with histologically confirmed invasive rectal adenocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be locally advanced rectal cancer patients with histologically confirmed rectal adenocarcinoma. 20 patients will be recruited to the study.
Key inclusion criteria (6 listed)
- Histologically confirmed rectal adenocarcinoma.
- T stage 3b or above and/or high risk factors eg. EMVI, nodal disease.
- Participant able to give written informed consent.
- Male or non-pregnant female ≥18 years of age.
- Scheduled to undergo radical radiotherapy.
Key exclusion criteria (7 listed)
- Contra-indications to MRI, such as claustrophobia, excessive body weight, MRI unsafe implants, ferrous metal in the body, insufficient information on prior surgeries. MRI conditional implants where conditions cannot be met (e.g pacemakers).
- Any previous radiotherapy to the pelvis.
- Inflammatory bowel disease.
- Other severe or uncontrolled systemic disease or evidence of any other significant disorder or lab finding that makes it undesirable for the patient to participate in the study, as determined by the treating clinician.
- History of physical or psychiatric disorder that would prevent informed consent and compliance with the protocol.
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 |
|---|---|---|
| Observational single centre feasibility studyPatients scheduled to undergo standard of care neo. adjuvant radiotherapy prior to surgery. | Other | Colorectal cancer patients |
Primary outcome
Feasibility of acquiring serial MRI for advanced radiotherapy planning of rectal cancer.
Time frame: 18 months
Feasibility defined as 70% of study participants completing a baseline and repeat scan acquisition.
4 secondary outcomes
Volumetric radiotherapy target volume data- longitudinal changes in radiotherapy target volume data measured in cubic centimetres
Time frame: 18 Months
Quantification of MR image parameters- extraction of apparent diffusion coefficient (ADC) from defined radiotherapy target volumes on functional MR images
Time frame: 18 months
Quantify inter-observer target delineations
Time frame: 18 months
Health-related quality of life of study participant using European Organisation for Research and Treatment of Cancer patients' validated tools EORTC QLQ CR30 and EORTC CR 29
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No. Currently 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.
Ms Lynsey Devlin principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer (CRC), run by NHS Greater Glasgow and Clyde 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ms Lynsey Devlin (0141 301 9902, lynsey.devlin@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of acquiring serial MRI for advanced radiotherapy planning of rectal cancer. (time frame: 18 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 12 Feb 2025.