Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing (Split-Dose)
September 14, 2017 updated by: Carrie Hruska, Mayo Clinic
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carrie B Hruska, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
July 24, 2012
First Submitted That Met QC Criteria
July 26, 2012
First Posted (Estimate)
July 31, 2012
Study Record Updates
Last Update Posted (Actual)
September 18, 2017
Last Update Submitted That Met QC Criteria
September 14, 2017
Last Verified
September 1, 2017
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.