Clinical trial · Observational
ART: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy
Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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)
- description
- 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 outcomes (4)
- measure
- Changes on DCE MRI, Perfusion CT, T2* MRI, FDG PET
- timeFrame
- Fraction 8-10 of CRT (Day 10-12)
- description
- 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).
- measure
- Correlation of findings on different functional images.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDRobinson 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. PMID 31506182
- DERIVEDSabbagh 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. PMID 30583927