Know Cancer

or
forgot password

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


N/A
25 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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 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.


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)

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Michael K. O'Connor, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

09-002678

NCT ID:

NCT01024114

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • MBI
  • Molecular Breast Imaging
  • Breast Cancer
  • Positive Molecular Breast Imaging scan.
  • Breast Neoplasms

Name

Location

Mayo Clinic - Rochester Rochester, Minnesota  55905