Health TrialsbyHealthPanel

Advances in Imaging to Assess Response in Rectal Cancer

ConditionColorectal Cancer (CRC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNHS Greater Glasgow and Clyde

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population will be locally advanced rectal cancer patients with histologically confirmed rectal adenocarcinoma. 20 patients will be recruited to the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational single centre feasibility study

    Other intervention

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Colorectal cancer patients1 intervention

Trial outcomes

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.

Time frame
18 months

Secondary outcomes

1

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.

Time frame
18 Months
2

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).

Time frame
18 months
3

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.

Time frame
18 months
4

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.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NHS Greater Glasgow and Clyde

Lead sponsor

Source ClinicalTrials.gov
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