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

Anal Cancer Clinical Trial

— ART  

Official title:

Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145416
• Other study ID #: OCTO-051
• Status: Completed
• Start date: January 27, 2015
• Est. completion date: April 12, 2018

Study information

• Verified date: June 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 12, 2018
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Carcinoma, Squamous Cell

Locations

Country	Name	City	State
United Kingdom	Churchill Hospital	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Evaluate use of dynamic data acquired during FDG PET scan	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)
Other	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
Primary	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)
Secondary	Changes on DCE MRI, Perfusion CT, T2* MRI, FDG PET	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).	Fraction 8-10 of CRT (Day 10-12)
Secondary	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
Secondary	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)
Secondary	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

External Links

•   Oncology Clinical Trials Office homepage