None listed
Conditions
Brief summary
This observational study aims to explore the use of diffusion-weighted magnetic resonance imaging (DW-MRI) and dynamic contrast enhanced MRI (dCE-MRI) in predicting treatment outcome in patients with anal cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with anal canal squamous cell carcinoma (SCC) managed with definitive chemoradiotherapy with concurrent Mitomycin-C and 5-FU. Study details All participants will continue their standard chemotherapy and radiotherapy as planned. Patients participating in this study will have multiparametric MRI's performed at the following four time points: 1) prior to chemoradiotherapy, 2) during the second week of treatment, 3) during the fourth week of treatment, 4) at 6-8 weeks post treatment. Each scan involves the use of an injected contrast agent and is of approximately 45 minutes length. Participants will be followed-up for 6 months to determine treatment outcomes. Correlations between the different types of MRIs and tumour response will determine whether DW-MRI and dCE-MRI can predict tumour response and treatment outcome.
Interventions
Single arm, multicentre, prospective, observational biomarker study.
Patients will have standard chemotherapy and radiotherapy. Patients participating in this study will have a multiparametric MRI at the following four time points:
1. Prior to chemoradiotherapy
2. During the second week of treatment
3. During the fourth week of treatment
4. At 6-8 weeks post treatment
A Multiparametric MRI incorporates standard morphological as well as diffusion weighted and dynamic contrast enhanced sequence
Single arm, multicentre, prospective, observational biomarker study. Patients will have standard chemotherapy and radiotherapy. Patients participating in this study will have a multiparametric MRI at the following four time points: 1. Prior to chemoradiotherapy 2. During the second week of treatment 3. During the fourth week of treatment 4. At 6-8 weeks post treatment A Multiparametric MRI incorporates standard morphological as well as diffusion weighted and dynamic contrast enhanced sequences. Each MRI takes approximately 45 minutes. All sequences will be performed on all patients at each of the 4 time points. Observation post treatment is for 6 months.
Sponsors
Dr Michael Jones
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient capable of providing informed consent 2. Patient deemed suitable for protocol treatment as assessed by Radiation and Medical Oncologists 3. Histological diagnosis of invasive primary squamous cell carcinoma of the anal canal 4. TNM Stage: T2-4, N0-3 based on the following diagnostic workup a. History & physical examination b. Digital Rectal Exam (DRE) stating primary size and distance from anal verge c. Groin examination with documentation of any lymphadenopathy (location: right vs. left; medial vs. lateral; mobile vs. fixed; and size) d. Clinically positive nodes i .Small inguinal nodes < 1cm in size felt to be clinically positive must be confirmed via biopsy ii. A biopsy is not needed for enlarged inguinal, perirectal or pelvic nodes on examination or imaging if >1cm and considered to be clinically positive e. Anal biopsy f. CT abdomen and pelvis g. PET/CT
Exclusion criteria
1. ECOG performance status >2 2. Significant comorbidities that would interfere with the completion of treatment 3. Renal insufficiency (Creatinine > 150) 4. Prior radiotherapy to the pelvis that would overlap in the treatment fields 5. Prior surgery for cancer of the anus that removed all macroscopic cancer 6. Prior systemic chemotherapy for anal cancer 7. Evidence of distant metastases (M1) if this precludes radical pelvic treatment 8. Women who are pregnant or lactating 9. Inability to have a MRI due to: a. Implanted magnetic metal e.g. intraocular metal b. Pacemaker / Implantable defibrillator c. Extreme claustrophobia
Outcome results
None listed