Breast Cancer
Conditions
Keywords
suspicious, lesion, breast, cancer, screening, mammogram, negative
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTMolecular breast imaging
Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica)
Sponsors
Friends for an Earlier Breast Cancer Test
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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) |
Countries
United States
Participant flow
Pre-assignment details
83 subjects were enrolled (consented) but 1 subject was found not to meet eligibility criteria, so did not participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Molecular Breast Imaging Molecular Breast Imaging at 4 mCi dose and at 8 mCi dose, consecutively.
Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica) | 82 |
| Total | 82 |
Baseline characteristics
| Characteristic | Molecular Breast Imaging | — |
|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 11.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | — |
| Race (NIH/OMB) Asian | 0 Participants | — |
| Race (NIH/OMB) Black or African American | 0 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | — |
| Race (NIH/OMB) White | 82 Participants | — |
| Region of Enrollment United States | 82 Participants | — |
| Sex: Female, Male Female | 82 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 82 |
| other Total, other adverse events | 0 / 82 |
| serious Total, serious adverse events | 0 / 82 |
Outcome results
Primary
Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI.
Time frame: At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)
Population: Of 82 patients recruited to the study (prior to breast biopsy), 34 had a histologically-proven diagnosis of breast cancer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Molecular Breast Imaging | Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI. | 4 mCi | 29 cancers detected |
| Molecular Breast Imaging | Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI. | 8 mCi | 30 cancers detected |