Predictive Value of FMISO-PET, FDG-PET-CT, DWI-MRI and DCE-MRI Scans for Patients With Anal Cancer Receiving Radiotherapy +/- Chemotherapy

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the predictive value of 18F-fluoromisonidazol-PET (FMISO-PET), 2-18F-fluoro-2-deoxy-d-glukose-PET-CT (FDG-PET-CT), Diffusion-Weighted Magnetic Resonance Imaging (DWI-MRI) and Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) for patients with anal cancer receiving radiation therapy +/- chemotherapy (Cisplatin and 5-FU).

Detailed Description
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The study involves tree MRI sessions, two FDG-PET-CT sessions and one FMISO-PET session. The FMISO-PET session is presently not carried out because of delivery problems. The production of 18F-fluoromisonidazol at The Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Herlev, Denmark has not jet been approved by the Danish Medicines Agency.

Official Title
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18F-FMISO-PET, 18F-FDG-PET/CT, DWI-MRI and DCE-MRI Scans as Predictors of Response to Radiotherapy +/- Chemotherapy in Patients With Anal Cancer.

Conditions
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Anal Cancer

Intervention / Treatment
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* Other: FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological confirmation of invasive primary squamous cell carcinoma of the anal canal or perianal region. TNM stage T1-4, N0-3, M0-1 Treatment with curative intent Age > 18 years Able to provide informed consent Exclusion Criteria: Contraindication to MRI imaging Cardiac pacemaker Major obesity Serious claustrophobia Other malignant disease (except non-melanoma skin cancer) in a period of 5 years prior to imaging study Poorly regulated diabetes mellitus despite insulin Pregnancy Breast feeding Known allergy to iv contrast agent Major psychiatric illness which would prevent participation in the imaging study Infectious wounds on the legs Unacceptable kidney function Major language difficulties which would prevent participation in the imaging study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anal cancer<br> | Other: FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)<br>* This study involves 6 imaging sessions. One FMISO-PET before radiation therapy, one FDG-PET-CT before radiation therapy and one FDG-PET-CT during radiation therapy and tree Magnetic Resonance imaging (MRI) sessions with one session before radiation therapy, one session during radiation therapy and one sessions post radiation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | Primary tumor 18-F-deoxyglucose (FDG) uptake before radiation and during week 3 of radiation. Primary tumor apparent diffusion coefficient before radiation and during week 3 of radiation and 6-8 weeks post radiation Primary tumor perfusion coefficient before radiation and during week 3 of radiation and 6-8 weeks post radiation Primary tumor 18-F-Fluoromisonidazol (FMISO) uptake before radiation | 6-8 weeks post radiation |