Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01653964

Run by

Mayo Clinic

People needed

83

Starts

2012-07-01

Expected to finish

2016-05-01

Last updated by the study team

2017-09-18

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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