ART: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy

Study Overview
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Brief Summary
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This is a single arm, single centre imaging study which will be offered to all consecutive, eligible patients receiving radical chemoradiation therapy (CRT) for anal cancer within Oxford University Hospitals. Investigations Dynamic contrast enhanced magnetic resonance imaging (DCE MRI) Diffusion weighted magnetic resonance imaging (DWI MRI) MRI scan designed to measure the T1 or produce T1-weighed images (T1 MRI) MRI scan designed to measure the T2* or produce T2*-weighed images (T2* MRI) Perfusion computed tomography (pCT) Fludeoxyglucose positron emission tomography (FDG PET/CT) Study Design: Observational Target Population: Patients undergoing radical CRT for anal cancer in Oxford University Hospitals National Health Service (NHS) Trust. Duration on study: Patients should be on study for a maximum of 5 months. Patient care post-trial: Follow up as per local standard. No. of Study Site(s): Single Centre, United Kingdon (UK) End of study: Last Patient, last assessment of response. Patients should be on study for a maximum of 5 months.

Official Title
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Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy

Conditions
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Anal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed invasive primary squamous carcinoma of the anus. Patients must be fit and scheduled to receive radical CRT with curative intent. Any stage tumor 2-node 0 (T2N0) Male or female, Age 18 years+. The patient is willing and able to comply with the images and protocol for the duration of the study. Written (signed and dated) informed consent. Exclusion Criteria: Pregnant or breast-feeding women or women of childbearing potential unless effective methods of contraception are used. Previous pelvic radiotherapy Patients with a pacemaker or any other implanted metal which would preclude MRI scan. Patients with a prosthetic hip. Patients receiving radiotherapy with palliative intent. Active medical or psychological illness that would render the patient unsuitable for the additional imaging proposed in this study, at the discretion of the investigator Additional criteria for optional oxygen breathing procedure: Patients with Chronic Obstructive Pulmonary Disease Any patient not felt to be suitable for supplementary oxygen as considered by an appropriately trained clinician

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on DW MRI during CRT in anal cancer. | The number of patients with a change in ADC values of <20% between pre-CRT DW MRI and repeat DW MRI following 8-10 fractions of CRT | Fraction 8-10 of CRT (Day 10-12) compared with prior to CRT (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on DCE MRI, Perfusion CT, T2* MRI, FDG PET | Changes on alternative functional imaging modalities following 8-10 fractions of CRT: DCE MRI - Change in amplitude and rate of gadolinium enhancement. Perfusion CT - Changes in perfusion maps represented by blood flow, blood volume, mean transition time and permeability surface area. T2* MRI - Change in T2* values in hypoxic regions (with or without oxygen) FDG PET - Change in tumour uptake (% change in SUVmax). | Fraction 8-10 of CRT (Day 10-12) | 
| Correlation of findings on different functional images. | Correlate size and position of regions of poor vascularity / hypoxia between different images at the same timepoint using volume, centre of mass and overlap comparisons. | Both prior to CRT day 1 and fraction 8-10 | 
| Correlation of baseline functional images with outcome of CRT | Compare volumes of poor vascularity / hypoxia in baseline scans (as described above) with complete response rates 3 months after CRT. | 3 months post CRT compared with prior to CRT (Day 1) | 
| Correlation of the change in functional images over CRT with outcome of CRT | Change in volumes of poor vascularity / hypoxia in baseline scans (as described above) with complete response rates 3 months after CRT. | 3 months post CRT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imaging, Chemoradiotherapy