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NCT01024114 Clinical Trial

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

Breast Cancer Clinical Trial

Official title:
Pilot Study to Evaluate the Incremental Diagnostic Value of a Combined Molecular Breast Imaging / Breast Tomosynthesis Modality

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01024114
Other study ID # 09-002678
Secondary ID
Status Withdrawn
Phase N/A
First received November 30, 2009
Last updated April 16, 2012
Start date July 2009

Study information
Verified date April 2012
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Female
Age group 25 Years and older
Eligibility 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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic - Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

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