Evaluation of Magnetic Resonance Imaging (MRI) vs Molecular Breast Imaging (Tc-MBI) in Breast Cancer Patients

NCT02024074 | Terminated Phase 1 DMC

• 1 other identifier: IRB00064317
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the usefulness of Tc-99m Sestamibi Molecular Breast Imaging as an imaging modality for breast cancer screening. Tc-MBI has shown significantly higher sensitivity and equivalent specificity in the detection of breast cancer among high risk women when compared to mammography. However, there is little published data comparing Tc-MBI to MRI for evaluating extent of disease in women with known breast cancer. The study will target twenty (20) women with newly diagnosed breast cancer who are scheduled to undergo biopsy of additional suspicious lesions that were identified on standard of care contrast- enhanced breast MRI. Prior to the biopsy, these subjects will receive a Tc-MBI scan of the breast. The results from both imaging methods will be compared to histological findings. These results may be used to design larger and more comprehensive studies with an overarching goal to determine if there is a role for Tc-MBI in the pre-operative evaluation of patients with known breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Cancer detection rates by Sestambi imaging

  This study will determine whether Tc-MBI is useful in the pre-operative evaluation of patients with known breast cancer. Patients will be tracked for 2 years to see if histological evidence is found to confirm Tc-MBI findings

  Up to 2 years

Study Arms (1)

Sestamibi(Tc- MBI) scan of the breast

OTHER

Other: Sestamibi (Tc-MBI) scan of the breast

Interventions

Sestamibi (Tc-MBI) scan of the breast OTHER

Patients will be given 8mCi of Sestamibi intravenously. following which Sestamibi scan will be performed on the breast. Sestamibi scan will be done prior to any surgical procedure..

Sestamibi(Tc- MBI) scan of the breast

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women Patients must be 18 years of age or older. Patients will have biopsy proven unilateral breast cancer with ipsilateral or contralateral suspicious lesions on contrast-enhanced breast MRI and be a candidate for additional tissue biopsy.
• Patients must be able to remain still for Tc-MBI scanning Patients must be able to provide written informed consent

You may not qualify if:

• Men, age less than 18, inability to remain still for Tc-MBI scanning, cannot provide written informed consent, known untreated bilateral breast cancer, evidence of distant metastasis disease (M=1), pregnancy.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine, Department of Radiology

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: December 31, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 6, 2015

Record last verified: 2015-02

Locations

US (1)