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Study to Evaluate the Diagnostic Value of a Combined Molecular Breast Imaging/ Breast Tomosynthesis Modality

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Amy L. Conners, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01024114
First received: November 30, 2009
Last updated: April 16, 2012
Last verified: April 2012
History of Changes

November 30, 2009
April 16, 2012
July 2009
December 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01024114 on ClinicalTrials.gov Archive Site
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Study to Evaluate the Diagnostic Value of a Combined Molecular Breast Imaging/ Breast Tomosynthesis Modality
Pilot Study to Evaluate the Incremental Diagnostic Value of a Combined Molecular Breast Imaging / Breast Tomosynthesis Modality

The purpose of this pilot study is to investigate the potential clinical benefits of combining two new diagnostic tools to provide co-registered anatomical and functional information in the breast in patients with suspected breast cancer.

The purpose of this pilot study is to obtain preliminary data on a new way of imaging the breast that combines the benefits of a 3-D anatomical technique (Digital Tomosynthesis) with those of a functional imaging technique (Molecular Breast Imaging). Combining data from these 2 modalities would provide co-registered functional and anatomical information on the breast, in the same way that PET/CT does today in oncology. This should greatly facilitate the evaluation and biopsy of lesions seen on MBI but occult on conventional mammography.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

All patients will have had a molecular breast imaging study as part of their participation in one of the current research protocols evaluating this technology. A requirement for inclusion in this study is that patients will have had a digital mammography examination at Mayo Clinic within the past 30 days.
Breast Cancer
Not Provided
Positive MBI scan
Women who are previously enrolled in an MBI study that present with a positive MBI scan.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • over the age of 25
  • enrolled in one of the following protocols:

IRB # 08-005522: Evaluation of Molecular Breast Imaging in Patients with a High Likelihood of Ductal Carcinoma in Situ. 07-004241: Molecular Breast Imaging in the Preoperative Evaluation of Women with Biopsy Proven Breast Cancer. 1204-03: Evaluation of a Small Field of View Gamma Camera for Scintimammography in Patients with Atypical Ductal Hyperplasia, Atypical Lobular Hyperplasia, and Lobular Carcinoma In Situ. 07-003397: Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation. 17-05: Determination of the Sensitivity of a Dual-Headed Small Field of View Gamma Camera for the Detection of Small Breast Lesions.

  • Digital mammogram at the Mayo Clinic within the past 30 days

Exclusion Criteria:

  • They are unable to understand and sign the consent form
  • They are pregnant or lactating
  • They are physically unable to sit upright and still for 40 minutes.
  • Recently enrolled on one of the ongoing tomosynthesis vs. mammography studies (rationale - avoid performing duplicate tomosynthesis studies in the same patient)
Female
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01024114
09-002678
No
Amy L. Conners, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Michael K. O'Connor, Ph.D Mayo Clinic
Mayo Clinic
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP