Advances in Imaging to Assess Response in Rectal Cancer (AIR-REC)

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer (CRC)
• Intervention / Treatment: Other: Observational single centre feasibility study

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Ms Lynsey Devlin; Phone Number: 0141 301 9902; Email: lynsey.devlin@nhs.scot
• Study Contact Backup: Name: Ms Aileen Duffton, PhD Cancer sciences; Phone Number: 0141 301 7428; Email: aileen.duffton@nhs.scot

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G120YN
    • Recruiting
    • Beatson West of Scotland Cancer Centre
    • Contact: Ms Lynsey Devlin; Phone Number: 0141 301 9902; Email: lynsey.devlin@nhs.scot
    • Contact: Ms Aileen Duffton, PhD Cancer sciences; Phone Number: 0141 301 7428; Email: aileen.duffton@nhs.scot
    • Contact: Ms Lynsey Devlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Colorectal cancer patients; Patients with histologically confirmed invasive rectal adenocarcinoma	Other: Observational single centre feasibility study; Patients scheduled to undergo standard of care neo. adjuvant radiotherapy prior to surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	18 months

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Investigators: Principal Investigator: Ms Lynsey Devlin, NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): June 26, 2026

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: MRI; Colorectal cancer; CRC; colorectal cancer (crc)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: GN23ON218; 329328 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No