Pre-biopsy With Dynamic Acquisitions
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Purpose
This study is being done to test the ability of an investigational mammography camera to find small tumors in patients' breasts.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Device: Molecular Breast Imaging (MBI) Device: CZT semiconductor detectors |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Determination of Sensitivity of a Dual-Headed Small Field of View Gamma Camera for the Detection of Small Breast Lesions |
- To determine the sensitivity of the dual-head system relative to single-head for detection of sub 10 mm breast lesions, and to determine the number of images that need to be acquired. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 185 |
| Study Start Date: | August 2005 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
-
Device: Molecular Breast Imaging (MBI)
If you agree to take part in this study, you will be asked to remove your clothes from the waist up and put on a gown. A female technologist will give you an injection of Tc-99m sestamibi in a vein in your arm. This is a drug routinely used for breast imaging. About 10 minutes after your injection, you will be asked to sit in a chair for about 40 minutes. The technologist will position your breast between two small cameras. The cameras will apply a very light compression to your breast to make sure there is no movement during the picture. We will take two pictures of each breast. Each picture takes 10 minutes. You will also be asked to fill out a short questionnaire. If you are found to have additional breast lesions, your doctor and radiologist will be notified so that additional imaging or biopsies can be performed.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients that are scheduled to have a biopsy at the Mayo Clinic in Rochester, MN and have a lesion less the 2 cm
Inclusion Criteria:
- Have a lesion on Mammogram, Ultrasound or MRI that measured < 2 cm and considered suspicious or suggestive of malignancy
- Scheduled for biopsy of lesion
- > 18 years of age
- Negative pregnancy test, postmenopausal, or surgically sterilized
Exclusion Criteria:
- Prior needle biopsy
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | Michael K. O'Connor, Ph.D. | Mayo Clinic |
| Principal Investigator: | Deborah J. Rhodes, M.D. | Mayo Clinic |
| Principal Investigator: | Douglas A. Collins, M.D. | Mayo Clinic |
| Principal Investigator: | Carrie B. Hruska, Ph.D. | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Michael O'Connor, Ph.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00943644 History of Changes |
| Other Study ID Numbers: | 17-05, BCTR0504394 |
| Study First Received: | November 10, 2008 |
| Last Updated: | December 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
MBI Breast Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013