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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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ClinicalTrials.gov Identifier: NCT01330186
Recruitment Status : Unknown
Verified April 2011 by Copenhagen University Hospital at Herlev.
Recruitment status was:  Recruiting
First Posted : April 6, 2011
Last Update Posted : April 12, 2011
Sponsor:
Information provided by:
Copenhagen University Hospital at Herlev

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).

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

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
Estimated Enrollment : 50 participants
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.
Study Start Date : February 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eva Serup-Hansen, MD, Department of Oncology, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01330186     History of Changes
Other Study ID Numbers: GI 1026
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: April 2011

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