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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study to Evaluate the Incremental Diagnostic Value of a Combined Molecular Breast Imaging / Breast Tomosynthesis Modality

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Enrollment: 0
Study Start Date: July 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Positive MBI scan
Women who are previously enrolled in an MBI study that present with a positive MBI scan.

Detailed 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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024114

Locations
United States, Minnesota
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michael K. O'Connor, Ph.D Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Amy L. Conners, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01024114     History of Changes
Other Study ID Numbers: 09-002678
Study First Received: November 30, 2009
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
MBI
Molecular Breast Imaging
Breast Cancer
Positive Molecular Breast Imaging scan.

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

ClinicalTrials.gov processed this record on April 14, 2014