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

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Observational

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 Summary: 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.
Sponsor: Copenhagen University Hospital at Herlev

Current Primary Outcome: Tumor response [ Time Frame: 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


Original Primary Outcome: Tumor response [ Time Frame: 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-FMISO uptake before radiation


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Copenhagen University Hospital at Herlev

Dates:
Date Received: April 5, 2011
Date Started: February 2011
Date Completion: May 2012
Last Updated: April 11, 2011
Last Verified: April 2011