Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing
NCT ID: NCT01653964
Last Updated: 2017-09-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
83 participants
INTERVENTIONAL
2012-07-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Molecular breast imaging
Molecular Breast Imaging at 4 mCi dose and at 8 mCi dose, consecutively.
Molecular breast imaging
Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica)
Interventions
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Molecular breast imaging
Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica)
Eligibility Criteria
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Inclusion Criteria
-At least one breast lesion detected by mammogram, ultrasound or breast MRI that measures \< 20 mm in greatest dimension, presents as a mass, is considered suspicious or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4 or 5), and is scheduled for core-needle biopsy or surgical biopsy.
OR
-At least one breast lesion that measures between \> 10 mm but \< 20 mm in greatest dimension, presents as a mass, is biopsy-proven as malignant, and is scheduled for surgical resection.
AND
* Age \> 40 years
* Negative pregnancy test, postmenopausal, or surgically sterilized
Subgroup 2, Patients without known breast lesions:
* Negative screening mammogram performed at Mayo Clinic Rochester within 15 months prior to performance of study MBI
* No signs or symptoms of breast disease
* Age \> 40 years
* Negative pregnancy test, postmenopausal, or surgically sterilized
Exclusion Criteria
* MBI is performed after biopsy and neo-adjuvant chemotherapy is planned prior to surgery. Reason: true tumor size will not be able to be ascertained from the final pathology findings
* Breast implants. Reason: cases with breast implants will be easily identifiable on blinded interpretation to take place at the study end
* Suspected that breasts will not fit in the MBI field of view. Reason: cases that require tiled views or additional views will be easily identifiable on blinded interpretation to take place at the study end
* Only one breast remaining. Reason: unilateral cases will be easily identifiable on blinded interpretation to take place at the study end; injection timing is designed for bilateral views
* Pregnancy test (if necessary) is not negative, or the patient is unable to complete the pregnancy test
* Physically unable to sit upright and still remain still during two consecutive MBI studies over the course of a 2-hour period.
40 Years
FEMALE
Yes
Sponsors
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Friends for an Earlier Breast Cancer Test
UNKNOWN
Mayo Clinic
OTHER
Responsible Party
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Carrie Hruska
Prinicipal Investigator
Principal Investigators
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Carrie B Hruska, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic News
Mayo Clinic You Tube Channel
Other Identifiers
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12-004437
Identifier Type: -
Identifier Source: org_study_id