None listed
Conditions
Brief summary
This study aims to investigate whether the combination of FDG-PET imaging, and blood sampling will lead to more accurate assessment of anal cancer location and progression. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with anal cancer (specifically, anal squamous cell carcinoma) and your doctor has determined that chemoradiation therapy would be a suitable treatment option for you. Study details All participants who choose to enrol in this study will be asked to provide up to 3 blood samples which will be tested for cancer markers. Participants will also be asked to undergo a form of imaging called FDG-PET scanning which will involve injection of a dye prior to the scan. It is anticipated that completion of the scan and blood samples will take no more than 2 hours. Participants will be asked to complete 1 FDG-PET scan prior chemoradiotherapy, 1 FDG-PET throughout the course of their chemoradiotherapy which is usually delivered over 5-6 weeks and maximum of 2 FDG PET post chemoradiotherapy. It is hoped that the findings from this investigations will provide new cancer markers that can be used to determine how well patients with anal cancer are responding to chemoradiation treatment. If this study finds new markers that look promising, these may be used to guide treatment decisions and could lead to improved outcomes for patients with anal cancer.
Interventions
FDG-PET, Biomarker testing with optional MRI will be administered to participants eligible and consenting to this study.
Patients will receive 5-6 weeks of CRT depending on their staging.
FDG- 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 clinic
FDG-PET, Biomarker testing with optional MRI will be administered to participants eligible and consenting to this study. Patients will receive 5-6 weeks of CRT depending on their staging. FDG- 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. The 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. Detection of HPV 16 and 18 viral DNA is detected and quantified from the patient’s plasma through a droplet digital polymerase chain reaction (ddPCR) test. This is referred to as circulating tumour DNA in this instance, as the HPV DNA is integrated into the tumour cells. Collection of peripheral blood is required for HPV ctDNA testing. The baseline sample should be collected no more than 4 weeks prior to commencement of CRT. Blood will be collected and analysed 2 weeks into CRT, and 3 months after completion of CRT. To minimise additional venepuncture for patients, blood will be collected at the time of cannulation for either PET (in the nuclear medicine department at Liverpool Hospital) or CT scanning (Liverpool or Campbelltown Cancer Therapy Centres), wherever this is possible.
Sponsors
South Western Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Age greater than or equal to 18 - Patient willing and able to give written informed consent - Patient deemed suitable for CRT treatment protocol as determined by both a medical oncologist and a radiation oncologist - Biopsy confirming histological diagnosis of primary invasive anal squamous cell carcinoma, and documentation of p16 immunohistochemistry status - TNM stage T1-T4 N0-N1 M0 (AJCC 8th edition), determined by -Clinical groin examination -DRE -EUA or anoscopy- CT chest, abdomen and pelvis (with IV contrast unless contraindicated) -Documentation of size of primary lesion
Exclusion criteria
Women lactating, pregnant or of childbearing potential with inadequate contraception - Patients who have previously received systemic therapy for anal cancer, or previous radiotherapy to the pelvis - Previous HPV-related malignancy within the last 3 years - Macroscopic surgical resection of the primary anal cancer - P16 negative on immunohistochemical staining (note: equivocal staining pattern not an exclusion) - ECOG performance status >2 - Patients with significant medical or psychosocial conditions that may impact their ability to understand or complete the treatment protocol and study requirements - Distant metastatic disease (M1)
Outcome results
None listed