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Multi-parametric MRI for Therapeutic Response Prediction in Rectal Cancer

ABSTRACT: Interventions: Single arm prospective observationaI imaging biomarker study. Patients will have standard treatment, consisting of neoadjuvant chemoradiotherapy followed by surgery. There will be no change to the patient’s treatment by participating in this study. Patients participating in this study will have multi-parametric MRI and PET/CT at the following 3 time-points: 1. Prior to chemoradiotherapy 2. During the third week of chemoradiotherapy 3. Post chemoradiotherapy, within 1 week prior to surgery. A multi-parametric MRI incorporates standard morphological as well as diffusion weighted imaging and dynamic contrast enhanced sequences. The total follow-up duration will be 2 years from date of surgery. Primary outcome(s): Correlation of multi-parametric MRI (diffusion weighted imaging (DWI) and dynamic contrast enhanced (DCE)) at 3 Tesla with surgical histopathology tumour regression grade (TRG). Histopathological assessment will be performed on surgical specimens. TRG assessment will be performed as per the modified classification of Ryan et al set out in the AJCC Cancer Staging Manual, 7th Edition as follows: TRG 0 (complete response) - no viable cancer cells TRG 1 (moderate response) - single cells or small groups of cancer cells TRG 2 (minimal response) - residual cancer outgrown by fibrosis TRG 3 (poor response) - minimal or no tumour kill; extensive residual cancer. [At baseline pre-chemoradiotherapy, week 3 of chemoradiotherapy, and post-chemoradiotherapy (within 1 week prior to surgery) ]

DISEASE(S): Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Rectal Cancer

PROVIDER: 2464730 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Cohort: 10 patients with histologically proven squamous cell carcinoma (SCC) of the anus, presenting to Austin Health for chemo-radiotherapy from June 2015. Observation: for up to 3 years post-radiotherapy. Interventions additional to standard procedures for purpose of study are administered by qualified health professionals and include: Pre-radiotherapy imaging: During standard MRI imaging session – non-standard diffusion weighted MRI (dwMRI) and dynamic contrast enhanced (DCE) MRI scans within Radiology facility. During standard CT simulation session – additional CT scan in prone position within Austin Radiation Oncology. Post-Radiotherapy - 3-4 weeks post completion of radiotherapy - non-standard timepoint for these scans MRI session – including dwMRI and DCE MRI scans within Radiology facility. PET session - PET imaging within Austin Nuclear & Molecular Imaging department. A number of imaging scans are required to map disease for targeting of radiotherapy (RT), including CT, PET and MRI. Each provides slightly different information about the position, shape and composition of the disease that is used by a Radiation Oncologist to define where to target the radiation and how much radiation to deliver. We aim to add an extra, non-standard MRI imaging sequence called a diffusion weighted (dwMRI) scan, to understand the characteristics of the disease and how its use may change the size or shape of the target area so as to ensure complete treatment coverage and improved outcomes from treatment. Additionally, the use of contrast with MRI, dynamic contrast enhanced MRI (DCEMRI) has been shown in other cancer sites to help better identify and show the disease and to show response to treatment, and we wish to verify this in anal Primary outcome(s): Identify the differences in radiotherapy target volume definition on standard (CT, T1/T2 MRI and PET) versus non-standard imaging modalities (dwMRI & DCE-MRI).[2 years post-radiotherapy] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group

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Multi-parametric MRI for Therapeutic Response Prediction in Rectal Cancer

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