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

June 4, 2018 updated by: University of Oxford

Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible patients receiving radical CRT for anal cancer within Oxford University Hospitals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on DW MRI during CRT in anal cancer.
Time Frame: Fraction 8-10 of CRT (Day 10-12) compared with prior to CRT (Day 1)
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
Time Frame: Fraction 8-10 of CRT (Day 10-12)

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.
Time Frame: Both prior to CRT day 1 and fraction 8-10
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
Time Frame: 3 months post CRT compared with prior to CRT (Day 1)
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
Time Frame: 3 months post 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the use of T1 mapping in anal cancer
Time Frame: Fraction 8-10 of CRT (Day 10-12)
Evaluate change in T1 value (with or without oxygen) and compare with other MRI images.
Fraction 8-10 of CRT (Day 10-12)
Evaluate use of dynamic data acquired during FDG PET scan
Time Frame: Prior to CRT day 1 and Fraction 8-10 (Day 10-12)
Analyse baseline data from FDG PET scans at baseline and 8-10 fractions of CRT and compare to static scan results.
Prior to CRT day 1 and Fraction 8-10 (Day 10-12)
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.
Time Frame: Prior to CRT day 1, Fraction 8-10 (Day 10-12) and at end of CRT
Compare active PBM regions at baseline and Fraction 8-10 on FDG-PET scans to identify regions of RT induced suppression of active PBM Correlate suppressed active PBM regions with dose received and determine if radiotherapy re-planning could spare active regions without compromising target coverage or sparing of organs at risk (OARs).
Prior to CRT day 1, Fraction 8-10 (Day 10-12) and at end of CRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Oxford University Hospitals NHS Trust

Investigators

  • Principal Investigator: Rebecca Muirhead, MBCHB, MRCP, FRCR, MD, Oxford University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2015

Primary Completion (Actual)

December 8, 2017

Study Completion (Actual)

April 12, 2018

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 22, 2014

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCTO-051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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