At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Observational single centre feasibility study (other)
- How long the study runs
- Study runs about 19 months (dates as stated)
- About the drug or intervention
- Observational single centre feasibility study — other: Patients scheduled to undergo standard of care neo.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 20
- Started
- 2024-11-11
- Last checked
- 2025-02
Plain English Summary
What is this study?
- • Testing a new treatment for colorectal cancer (crc)
- • Clinical study - 20 participants
- • The goal of this observational study is to determine the feasibility of acquiring serial MRI images for advanced radiotherapy planning in colorectal patients
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with colorectal cancer (crc)
Where?
- • Glasgow - Beatson West of Scotland Cancer Centre
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓confirmed by a biopsy rectal adenocarcinoma.
- ✓T stage 3b or above and/or high risk factors eg. EMVI, nodal disease.
- ✓Participant able to give written agreement to take part.
- ✓Male or non-pregnant female ≥18 years of age.
- ✓Scheduled to undergo radical radiotherapy.
Who cannot take part
- ✗Any previous radiotherapy to the pelvis.
- ✗Inflammatory bowel disease.
- ✗History of physical or psychiatric disorder that would prevent agreement to take part and compliance with the protocol.
- ✗Patients with de-functioning stoma.
- ✗Major surgery within 28 days prior to trial entry.
See the full criteria
Where Is This Study? (1 UK site)
Beatson West of Scotland Cancer Centre
Glasgow G120YN, United Kingdom
How to Get in Touch
Ms Lynsey Devlin
Sponsor contactCONTACT
Ms Aileen Duffton, PhD Cancer Sciences
Sponsor contactCONTACT
