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Pre-biopsy With Dynamic Acquisitions

NCT ID: NCT00943644

Last Updated: 2011-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2010-09-30

Brief Summary

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This study is being done to test the ability of an investigational mammography camera to find small tumors in patients' breasts.

Detailed Description

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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.

Conditions

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Breast Cancer

Keywords

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MBI Breast Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Molecular Breast Imaging (MBI)

To determine the sensitivity of MBI

Intervention Type DEVICE

CZT semiconductor detectors

Dual headed CZT semiconductor detectors

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Susan G. Komen Breast Cancer Foundation

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Michael K. O'Connor, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Deborah J. Rhodes, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Douglas A. Collins, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Carrie B. Hruska, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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BCTR0504394

Identifier Type: -

Identifier Source: secondary_id

17-05

Identifier Type: -

Identifier Source: org_study_id