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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Copenhagen University Hospital at Herlev.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01330186
First received: April 5, 2011
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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).


Condition Intervention
Anal Cancer
Other: FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Tumor response [ Time Frame: 6-8 weeks post radiation ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 50
Study Start Date: February 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Anal cancer 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with anal canal or perianal cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330186

Contacts
Contact: Eva Serup-Hansen, MD +4538689084 evseha01@heh.regionh.dk
Contact: Hanne Havsteen, MD +4538682287 hahav@heh.regionh.dk

Locations
Denmark
Department of Oncology Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Eva Serup-Hansen, MD    +4538689084    evseha01@heh.regionh.dk   
Contact: Hanne Havsteen, MD    +4538682287    hahav@heh.regionh.dk   
Principal Investigator: Eva Serup-Hansen, MD         
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
  More Information

No publications provided

Responsible Party: Eva Serup-Hansen, MD, Department of Oncology, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01330186     History of Changes
Other Study ID Numbers: GI 1026
Study First Received: April 5, 2011
Last Updated: April 11, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Anus Neoplasms
Anus Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Rectal Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014