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

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Brief Title

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

Official Title

Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy

Brief Summary

      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 Type

Observational


Primary Outcome

Changes on DW MRI during CRT in anal cancer.

Secondary Outcome

 Changes on DCE MRI, Perfusion CT, T2* MRI, FDG PET

Condition

Anal Cancer



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

29

Start Date

January 27, 2015

Completion Date

April 12, 2018

Primary Completion Date

December 8, 2017

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rebecca Muirhead, MBCHB, MRCP, FRCR, MD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT02145416

Organization ID

OCTO-051


Responsible Party

Sponsor

Study Sponsor

University of Oxford

Collaborators

 Oxford University Hospitals NHS Trust

Study Sponsor

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


Verification Date

June 2018