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

University of Oxford

Status: Completed

Conditions: Anal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02145416

OCTO-051

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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