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.
18 Years
N/A
Both
Anal Cancer
Trial Information
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.
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Tumor response
Outcome Description:
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
Outcome Time Frame:
6-8 weeks post radiation
Safety Issue:
No
Authority:
Denmark: The Regional Committee on Biomedical Research Ethics
Study ID:
GI 1026
NCT ID:
NCT01330186
Start Date:
February 2011
Completion Date:
May 2012
Related Keywords:
- Anal Cancer
- Anus Neoplasms
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