Chief Investigator: 
Rebecca Muirhead

Sponsor: University of Oxford
Clinical Trials.gov Number: NCT02145416

Anal squamous cell carcinoma: Investigation of functional imaging during Chemoradiotherapy (CRT)

Study Design

A single centre observational study to evaluate changes in functional images (MRI, Perfusion - CT, & FDG PET) after treatment with chemoradiotherapy.

Study Population

Patients undergoing radical CRT for anal cancer in Oxford University Hospitals NHS Trust.

Study Status

The ART study closed to recruitment on 30th November 2017. Many thanks to all the participants, and to the clinical team at The Churchill for all of their hard work.

Target recruitment: 30 (27 evaluable) patients.

Final recruitment: 29.

Study Schema

Inclusion Criteria

  1. Histologically confirmed invasive primary squamous carcinoma of the anus.
  2. Patients must be fit and scheduled to receive radical CRT with curative intent.
  3. Any stage ≥ T2N0
  4. Male or female, Age ≥ 18 years
  5. The patient is willing and able to comply with the images and protocol for the duration of the study
  6. Written (signed and dated) informed consent

Exclusion Criteria

  1. Pregnant or breast-feeding women or women of childbearing potential unless effective methods of contraception are used
  2. Previous pelvic radiotherapy
  3. Patients with a pacemaker or any other implanted metal which would preclude MRI scan
  4. Patients receiving radiotherapy with palliative intent
  5. 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

Primary Objective

To evaluate changes on Diffusion Weighted MRI (DW MRI) during CRT in anal cancer.

Secondary Objectives

To evaluate changes on functional imaging (Dynamic Contrast Enhanced MRI (DCE MRI), Perfusion Computed Tomography (pCT), Blood Oxygen-dependent Magnetic Resonance Imaging (BOLD MRI), Fludeoxyglucose Positron Emission Tomography (FDG PET)) during CRT in anal cancer.

To correlate findings on different functional images.

To correlate baseline functional images with outcome of CRT.

To correlate the change in functional images over CRT with outcome of CRT.

Tertiary Objectives

To evaluate the use of T1 mapping in anal cancer.

To evaluate use of dynamic data acquired during FDG PET scan.

To use PET SUV data in a radiotherapy in silico modelling exercise to determine if dose sparing of active pelvic bone marrow (PBM) is possible without compromising target coverage by radiation.

Key Dates

Trial opened: 16 October 2014

Closed to Recruitment: 30th November 2017

Final analysis and publication: April 2019

Trial duration: 41 Months

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