Anal Cancer
Conditions
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.
Interventions
OTHERFMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)
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.
Sponsors
Copenhagen University Hospital at Herlev
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Contacts
Primary ContactEva Serup-Hansen, MD
Backup ContactHanne Havsteen, MD
Outcome results
None listed