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

Overview

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).

Full Title of Study: “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.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2012

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

  • Other: FMISO-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.

Arms, Groups and Cohorts

  • Anal cancer

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Copenhagen University Hospital at Herlev
  • Provider of Information About this Clinical Study
    • Eva Serup-Hansen, MD, Department of Oncology, Herlev Hospital
  • Overall Contact(s)
    • Eva Serup-Hansen, MD, +4538689084, evseha01@heh.regionh.dk

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