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

NCT01653964 | Completed Results DMC

• 1 other identifier: 12-004437
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

suspicious; lesion; breast; cancer; screening; mammogram; negative

Outcome Measures

Primary Outcomes (1)

• Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI.

  At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)

Study Arms (1)

Molecular breast imaging

EXPERIMENTAL

Molecular Breast Imaging at 4 mCi dose and at 8 mCi dose, consecutively.

Diagnostic Test: Molecular breast imaging

Interventions

Molecular breast imaging DIAGNOSTIC_TEST

Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica)

Molecular breast imaging

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Friends for an Earlier Breast Cancer Test: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic News
• Mayo Clinic You Tube Channel

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Carrie Hruska
• Organization: Mayo Clinic

hruska.carrie@mayo.edu

5072663991

Study Officials

• Carrie B Hruska, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 31, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 18, 2017
• Results First Posted: September 18, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)