N/A
N=82
Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01653964 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI. — 30; 29 cancers detected
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Molecular breast imaging (Diagnostic_test)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI. |
30; 29 | — |
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.
Eligibility Criteria
Inclusion Criteria
Subgroup 1, Patients with breast lesions:
-At least one breast lesion detected by mammogram, ultrasound or breast MRI that measures 10 mm but 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.
Data sourced from ClinicalTrials.gov (NCT01653964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.