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Use of Bone Scintigraphy, CT and MRI in Breast Cancer

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ClinicalTrials.gov Identifier: NCT00682253
Recruitment Status : Unknown
Verified September 2009 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : May 22, 2008
Last Update Posted : September 10, 2009
Sponsor:
Information provided by:

Study Description
Brief 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

Condition or disease
Breast Neoplasms

Study Design

Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use og Bone Scintigraphy, CT and MRI for Detection of Metastases in Patients With Breast Cancer
Study Start Date : May 2008
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
women aged 18-80 years with suspicision of disseminated breast cancer seen at Dept. of Oncology, Aarhus University Hospital
Criteria

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
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): NCT00682253


Contacts
Contact: Anni Eskild-Jensen, MD, PhD, DMSci +45 8949 2251 aej@ki.au.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
More Information

Responsible Party: Anni Eskild-Jensen, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00682253     History of Changes
Other Study ID Numbers: SKF-0805
First Posted: May 22, 2008    Key Record Dates
Last Update Posted: September 10, 2009
Last Verified: September 2009

Keywords provided by University of Aarhus:
SPECT/CT
MRI
Breast neoplasms

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases