{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2023"],"condition":["Cancer-Bowel-Anal","Anal Cancer"],"disease":["Cancer-bowel-anal","Anal Cancer"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/116890"],"location":["Australia"],"study_start_month":["12"],"repository":["ECRIN MDR"],"study_status":["Not yet recruiting"],"additional_accession":[]},"is_claimable":false,"name":"Investigating the role of interim Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) and blood markers to predict local and regional failure in patients with anal squamous cell carcinoma.","description":"Interventions: FDG-PET, Biomarker testing with optional MRI will be administered to participants eligible and consenting to this study.\nPatients will receive 5-6 weeks of CRT depending on their staging.\nFDG- PET scans will be performed at 3 timepoints for all patients. PETpre is to be completed prior to commencement of CRT, PETinterim during the second week of CRT and PETpost at 3 months post CRT. If the PETpost at 3 months post-treatment FDG-PET reveals a partial response, and the patient does not have clinically progressive disease, a 4th FDG-PET (PETprogress) will be performed at 5 months after completion of CRT.\nThe scans will be performed in the Nuclear Medicine department at Liverpool Hospital on a digital PET scanner (GE Healthcare, Discovery MI) in 3D mode for a total acquisition time of 1.5 – 2.5 min per bed position, adjusted according to the patient weight, from mid brain to proximal femora at about 1 hour post injection of a radiotracer called fluorodeoxyglucose (3.4 MBq/Kg). PET images will be reconstructed using GE VUE Point FX (Time of Flight) algorithm into a 256 x 256 matrix size with a slice thickness of 3.75 to 4.0 mm, and GE Q.Clear iterative reconstruction and if required Q-static motion-corrected respiratory gated algorithm for measurement of SUV and other volumetric parameters. Transmission scans and attenuation corrections will be obtained by using a 128-slice CT, using helical mode without the use of a contrast medium. CT images are to be acquired at 3.75 to 5mm slice thickness and reconstructed to a transaxial matrix size of 512 x 512. The current (30-40 mAs) and voltage (120-140 kV) are varied according to the patient weight. All FDG PET images will be analysed by the consensus reading of a nuclear medicine physician and a radiation oncologist.\n<\nPrimary outcome(s): Locoregional failure will be assessed by using FDG PET, MRI imaging and HPV ctDNA biomarker testing.[ 6 months post chemoradiation treatment];MTV 2.5 will be assessed using FDG-PET imaging.[ 2 weeks during chemoradiation treatment, 3 and 6 months post chemoradiation treatment];Diffusion weighted images with B values 50, 400 and 800 will be assessed using MRI[ 2 weeks during Chemoradiation treatment]\nStudy Design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy","dates":{"creation":"2023-12-15"},"accession":"116890","cross_references":{"Australian New Zealand Clinical Trials Registry":["ACTRN12623001098628"]}}