Predictive Value of FMISO-PET, FDG-PET-CT, DWI-MRI and DCE-MRI Scans for Patients With Anal Cancer Receiving Radiotherapy +/- Chemotherapy
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.
1 other identifier
observational
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 5, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedApril 12, 2011
April 1, 2011
1 year
April 5, 2011
April 11, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Anal cancer
Interventions
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.
Eligibility Criteria
Patients with anal canal or perianal cancer
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Oncology Herlev Hospital
Herlev, 2730, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 5, 2011
First Posted
April 6, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2012
Study Completion
May 1, 2012
Last Updated
April 12, 2011
Record last verified: 2011-04