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

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Brief Title

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

Official Title

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.

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.
    


Study Type

Observational


Primary Outcome

Tumor response


Condition

Anal Cancer

Intervention

FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)

Study Arms / Comparison Groups

 Anal cancer
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

50

Start Date

February 2011

Completion Date

May 2012

Primary Completion Date

February 2012

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +4538689084, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT01330186

Organization ID

GI 1026



Study Sponsor

Copenhagen University Hospital at Herlev


Study Sponsor

, , 


Verification Date

April 2011