Anal Cancer
Conditions
Keywords
Imaging, 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.
Interventions
None listed
Sponsors
Oxford University Hospitals NHS Trust
University of Oxford
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes on DW MRI during CRT in anal cancer. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of findings on different functional images. | 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. |
| Changes on DCE MRI, Perfusion CT, T2* MRI, FDG PET | 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). |
| Correlation of baseline functional images with outcome of CRT | 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. |
| Correlation of the change in functional images over CRT with outcome of CRT | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). |
| Evaluate use of dynamic data acquired during FDG PET scan | 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. |
| Evaluate the use of T1 mapping in anal cancer | Fraction 8-10 of CRT (Day 10-12) | Evaluate change in T1 value (with or without oxygen) and compare with other MRI images. |
Countries
United Kingdom
Outcome results
None listed