Clinical trial · Interventional
Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing
NCT01653964CI-TRIAL-00029573Split-DosecompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Molecular breast imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Molecular breast imaging
- description
- Molecular Breast Imaging at 4 mCi dose and at 8 mCi dose, consecutively.
- interventionNames
- Diagnostic Test: Molecular breast imaging
Primary outcomes (1)
- measure
- Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI.
- timeFrame
- At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.