Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing

Study Overview
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Brief Summary
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The primary objective of this work is to determine if half-dose Molecular Breast Imaging (MBI) performed with 4 mCi Tc-99m sestamibi with or without Wide Beam Reconstruction applied can achieve image quality and diagnostic accuracy non-inferior to that of standard MBI performed with 8 millicurie (mCi) Tc-99m sestamibi.

Detailed Description
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Recent implementation of dose reduction strategies for Molecular Breast Imaging now allow performance of MBI at an administered dose of 8 mCi Tc-99m sestamibi, which is reduced from the previously used doses of 20-30 mCi. In order to safely introduce MBI as a screening modality, we aim to perform MBI using 4 mCi Tc-99m sestamibi. An image processing algorithm called Wide Beam Reconstruction (WBR) has been tailored for MBI technology with the goal of allowing either the current administered dose or current acquisition time to be reduced by half.

Official Title
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Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Molecular breast imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subgroup 1, Patients with breast lesions: -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: Vacuum-assisted or excisional biopsy has been performed prior to the study MBI. Reason: these types of biopsies are more likely to remove all of the tumor 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Molecular breast imaging<br>Molecular Breast Imaging at 4 mCi dose and at 8 mCi dose, consecutively. | Diagnostic Test: Molecular breast imaging<br>* Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI. |  | At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lesion, breast, screening, mammogram, negative, suspicious, cancer