Clinical trial NCT06822634: Advances in Imaging to Assess Response in Rectal Cancer
Official title: Advances in Imaging to Assess Response in Rectal Cancer (AIR-REC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer (CRC)
Keywords: Colorectal cancer
colorectal cancer (crc)
CRC
MRI
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Feasibility of acquiring serial MRI for advanced radiotherapy planning of rectal cancer.
timeFrame: 18 months
Secondary outcomes:
measure: Volumetric radiotherapy target volume data- longitudinal changes in radiotherapy target volume data measured in cubic centimetres
timeFrame: 18 Months
measure: Quantification of MR image parameters- extraction of apparent diffusion coefficient (ADC) from defined radiotherapy target volumes on functional MR images
timeFrame: 18 months
measure: Quantify inter-observer target delineations
timeFrame: 18 months
measure: 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
timeFrame: 18 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Ms Lynsey Devlin
role: PRINCIPAL_INVESTIGATOR
References: