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

Breast Cancer Clinical Trial

Official title:

Performance of Tc99m Sestamibi Molecular Breast Imaging (Tc-MBI) Versus Magnetic Resonance Imaging in the Diagnosis of Breast Carcinoma: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02024074
• Other study ID #: IRB00064317
• Status: Terminated
• Phase: Phase 1
• First received: December 23, 2013
• Last updated: February 5, 2015
• Start date: November 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No