NCT01224873

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 11, 2011

Status Verified

October 1, 2010

Enrollment Period

2 years

First QC Date

October 19, 2010

Last Update Submit

January 10, 2011

Conditions

Breast Cancer

Keywords

breast cancerbone metastasiscomparison of diagnostic methodsbone scintigraphyfluoride PET/CTFDG-PET/CT

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

breast cancer patients who are treated at Rigshospitalet, DK

You may qualify if:

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

You may not qualify if:

  • age under 18 years
  • diabetes mellitus
  • pregnancy
  • other known malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Nuclear Medicine & PET, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Christine Winkler, Dr.

    Dep. of Nuclear Medicine & PET, Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Winkler, Dr.

CONTACT

christine.winkler@rh.regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2010

First Posted

October 20, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2012

Study Completion

September 1, 2013

Last Updated

January 11, 2011

Record last verified: 2010-10

Locations

DK(1)