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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by Copenhagen University Hospital at Herlev.
Recruitment status was:  Recruiting
Information provided by:
Copenhagen University Hospital at Herlev Identifier:
First received: April 5, 2011
Last updated: April 11, 2011
Last verified: April 2011
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 ]
    • 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.

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

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 identifier: NCT01330186

Contact: Eva Serup-Hansen, MD +4538689084
Contact: Hanne Havsteen, MD +4538682287

Department of Oncology Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Eva Serup-Hansen, MD    +4538689084   
Contact: Hanne Havsteen, MD    +4538682287   
Principal Investigator: Eva Serup-Hansen, MD         
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
  More Information

Responsible Party: Eva Serup-Hansen, MD, Department of Oncology, Herlev Hospital Identifier: NCT01330186     History of Changes
Other Study ID Numbers: GI 1026
Study First Received: April 5, 2011
Last Updated: April 11, 2011

Additional relevant MeSH terms:
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases processed this record on May 22, 2017