Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-004437
NCT ID: NCT01653964
Sponsor Protocol Number: 12-004437
About this study
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 mCi Tc-99m sestamibi.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Carrie Hruska, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available