Predictive Value of FMISO-PET, FDG-PET-CT, DWI-MRI and DCE-MRI Scans for Patients With Anal Cancer Receiving Radiotherapy +/- Chemotherapy
- Conditions
- Anal Cancer
- Interventions
- Other: FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)
- Registration Number
- NCT01330186
- Lead Sponsor
- Copenhagen University Hospital at Herlev
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Anal cancer FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI) -
- Primary Outcome Measures
Name Time Method Tumor response 6-8 weeks post radiation * 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Oncology Herlev Hospital
🇩🇰Herlev, Denmark