Clinical trial NCT02145416: ART: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy
Official title: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Cancer
Keywords: Imaging
Chemoradiotherapy
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
First posted: 2014-05-22
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients receiving radical CRT for anal cancer within Oxford University Hospitals

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.


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

Primary outcomes:
measure: Changes on DW MRI during CRT in anal cancer.
timeFrame: Fraction 8-10 of CRT (Day 10-12) compared with prior to CRT (Day 1)
Secondary outcomes:
measure: Changes on DCE MRI, Perfusion CT, T2* MRI, FDG PET
timeFrame: Fraction 8-10 of CRT (Day 10-12)
measure: Correlation of findings on different functional images.
timeFrame: Both prior to CRT day 1 and fraction 8-10
measure: Correlation of baseline functional images with outcome of CRT
timeFrame: 3 months post CRT compared with prior to CRT (Day 1)
measure: Correlation of the change in functional images over CRT with outcome of CRT
timeFrame: 3 months post CRT
Other outcomes:
measure: Evaluate the use of T1 mapping in anal cancer
timeFrame: Fraction 8-10 of CRT (Day 10-12)
measure: Evaluate use of dynamic data acquired during FDG PET scan
timeFrame: Prior to CRT day 1 and Fraction 8-10 (Day 10-12)
measure: 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.
timeFrame: Prior to CRT day 1, Fraction 8-10 (Day 10-12) and at end of CRT
Locations:
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Rebecca Muirhead, MBCHB, MRCP, FRCR, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robinson M, Muirhead R, Jacobs C, Cooke R, Chu KY, Van den Heuvel F, Ng S, Virdee P, Strauss V, Hawkins M. Response of FDG avid pelvic bone marrow to concurrent chemoradiation for anal cancer. Radiother Oncol. 2020 Feb;143:19-23. doi: 10.1016/j.radonc.2019.08.016. Epub 2019 Sep 7.
citation: Sabbagh A, Jacobs C, Cooke R, Chu KY, Ng SM, Strauss VY, Virdee PS, Hawkins MA, Aznar MC, Muirhead R. Is There a Role for an 18F-fluorodeoxyglucose-derived Biological Boost in Squamous Cell Anal Cancer? Clin Oncol (R Coll Radiol). 2019 Feb;31(2):72-80. doi: 10.1016/j.clon.2018.11.034. Epub 2018 Dec 21.