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Diagnosis of Bone Metastases in Breast Cancer: Bone Scintigraphy, Fluoride-PET and FDG-PET

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 October 2010 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01224873
First Posted: October 20, 2010
Last Update Posted: January 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  Purpose
Breast cancer can metastasize to the bones, which leads to another treatment if bone metastases are detected. The purpose of the study is to determine, if fluoride PET/CT is superior to bone scintigraphy with technetium. On the other side, the investigators would like to see if FDG-PET/CT is a reliable alternative to dedicated bone imaging to detect bone metastases in patients with breast cancer.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnosis of Sceletal Metastases in c. Mammae: 18F-NaF-PET/Lowdose-CT Versus 99mTc HDP Bone Scintigraphy

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Estimated Enrollment: 110
Study Start Date: October 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
breast cancer patients who are treated at Rigshospitalet, DK
Criteria

Inclusion Criteria:

  • histologically proven c. mammae
  • clinically suspicion of bone metastases

Exclusion Criteria:

  • age under 18 years
  • diabetes mellitus
  • pregnancy
  • other known malignant disease
  Contacts and Locations
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): NCT01224873


Contacts
Contact: Christine Winkler, Dr. christine.winkler@rh.regionh.dk

Locations
Denmark
Dep. of Nuclear Medicine & PET, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Christine Winkler, Dr.         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Christine Winkler, Dr. Dep. of Nuclear Medicine & PET, Rigshospitalet, Denmark
  More Information

Responsible Party: Dr. Christine Winkler, Department of Nuclear Medicine & PET
ClinicalTrials.gov Identifier: NCT01224873     History of Changes
Other Study ID Numbers: H-3-2010-019
First Submitted: October 19, 2010
First Posted: October 20, 2010
Last Update Posted: January 11, 2011
Last Verified: October 2010

Keywords provided by Rigshospitalet, Denmark:
breast cancer
bone metastasis
comparison of diagnostic methods
bone scintigraphy
fluoride PET/CT
FDG-PET/CT

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs