Advances in Imaging to Assess Response in Rectal Cancer

NCT06822634 | Recruiting

• 2 other identifiers: GN23ON218329328
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer (CRC)

Keywords

Colorectal cancer; colorectal cancer (crc); CRC; MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Volumetric radiotherapy target volume data- longitudinal changes in radiotherapy target volume data 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

  18 months

• Quantify inter-observer target delineations

  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

  18 months

Study Arms (1)

Colorectal cancer patients

Patients with histologically confirmed invasive rectal adenocarcinoma

Other: Observational single centre feasibility study

Interventions

Observational single centre feasibility study OTHER

Patients scheduled to undergo standard of care neo. adjuvant radiotherapy prior to surgery.

Colorectal cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

Beatson West of Scotland Cancer Centre

Glasgow, G120YN, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample, biopsy sample and stool sample

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ms Lynsey Devlin

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ms Lynsey Devlin

CONTACT

0141 301 9902; lynsey.devlin@nhs.scot

Ms Aileen Duffton, PhD Cancer Sciences

CONTACT

0141 301 7428; Aileen.duffton@nhs.scot

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: February 12, 2025
• Study Start: November 11, 2024
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): June 26, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)