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| Name | Class |
|---|---|
| Oxford University Hospitals NHS Trust | OTHER |
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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
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Changes on DW MRI during CRT in anal cancer. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes on DCE MRI, Perfusion CT, T2* MRI, FDG PET | Changes on alternative functional imaging modalities following 8-10 fractions of CRT:
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the use of T1 mapping in anal cancer | 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 |
Inclusion Criteria:
Exclusion Criteria:
Additional criteria for optional oxygen breathing procedure:
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Eligible patients receiving radical CRT for anal cancer within Oxford University Hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Muirhead, MBCHB, MRCP, FRCR, MD | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Churchill Hospital | Oxford | OX3 7LE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31506182 | Derived | 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. | |
| 30583927 | Derived | 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. |
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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| Fraction 8-10 of CRT (Day 10-12) |
| Correlation of findings on different functional images. | 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 | 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 | 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 |
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. | 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 |
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |