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NCT00682253 Clinical Trial

Use of Bone Scintigraphy, CT and MRI in Breast Cancer

Breast Neoplasms Clinical Trial

Official title:
Use og Bone Scintigraphy, CT and MRI for Detection of Metastases in Patients With Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00682253
Other study ID # SKF-0805
Secondary ID
Status Recruiting
Phase N/A
First received May 20, 2008
Last updated September 8, 2009
Start date May 2008
Est. completion date March 2011

Study information
Verified date September 2009
Source University of Aarhus
Contact Anni Eskild-Jensen, MD, PhD, DMSci
Phone +45 8949 2251
Email aej@ki.au.dk
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial Summary

A new imaging modality combining CT and tomographic bone scintigraphy (SPECT/CT) has enabled the combination of functional and anatomical imaging. Its use in cancer patients has not yet been evaluated or validated against a relative gold stand or clinical follow up. The purposes of this study are: 1: to validate the use of conventional planar bone scintigraphy and SPECT combined with low-dose or diagnostic CT and compare this to 3 Tesla MRI and clinical follow up. 2: to compare the specificity of low-dose and diagnostic CT, respectively, combined with bone SPECT. 3: to construct an algorithm for optimal evaluation of disease dissemination in breast cancer patients

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Histological verified breast cancer

- Age 18-80 years

- Investigation for metastases using imaging modality/modalities planned

- Written consent to participate in trial

Exclusion Criteria:

- Overweight limiting the use of MRI

- Metal parts in body

- Claustrophobia

- Allergy to contrast agents used in trial

- Pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

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