Study to Evaluate the Diagnostic Value of a Combined Molecular Breast Imaging/ Breast Tomosynthesis Modality
This study has been withdrawn prior to enrollment.
Sponsor:
Mayo Clinic
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
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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:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Diagnostic Imaging
U.S. FDA Resources
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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024114
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:
| 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 September 26, 2016