Effect of Surgery and Radiation Therapy on Tc-99M Sestamibi Uptake Patterns in Molecular Breast Imaging

The investigators hope to prove that radiation and surgical scarring does not result in changes that affect the MBI pattern 6-12 months after completion of treatment.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Molecular Breast Imaging

Detailed Description

The study will allow us to evaluate whether surgery and radiation have persistent effects on the breast tissue with regards to whether and how such changes impact MBI images and to determine whether the inflammatory changes due to treatment resolve within 6-12 months of completing treatment.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women who are seen in the Mayo Clinic Breast Clinic

Description

Inclusion Criteria:

• Women who have planned surgical excision of a lesion or have had a baseline MBI study as part of another MBI research protocol who are within 6-12 months of completing breast surgery who are able and willing to return to Mayo Clinic for a follow up MBI study once the 6-12 month interval is complete.
• Women who plan BCT for a malignant lesion or who are within 6-12 months of completing breast conserving treatment and have had a baseline MBI study as part of another MBI research protocol and are able and willing to return to Mayo Clinic for a follow up MBI study.

Exclusion Criteria:

• Women who do not require surgical excision of a breast lesion or breast conserving treatment for breast cancer.
• Patients undergoing mastectomy.
• Women who are pregnant or lactating.
• Women who are taking hormonal contraception or hormone replacement therapy (vaginal estrogen is permitted), or have used these agents within the previous 3 months.
• Women who have received chemotherapy within the previous 6 months or receive chemotherapy as part of their cancer treatment.
• Men (due to the very low incidence of male breast cancer and the lack of any available data regarding the use of scintimammography or MBI in men).
• Women under the age of 18 years.
• Women unable to sit comfortably during image acquisition.
• Women who are unable to return to Mayo Clinic for a follow up MBI scan 6-12 months after surgical excision or 6-12 months after completing radiation therapy for breast conservation.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery/Radiation Arm; Patients that have had surgery along with radiation therapy	Device: Molecular Breast Imaging; Molecular Breast Imaging
Surgery Arm; Patients that have had surgery of a benign lesion.	Device: Molecular Breast Imaging; Molecular Breast Imaging

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Nicole Sandhu, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: December 8, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (Estimate): December 9, 2009

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 13, 2013
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Surgery; Molecular; MBI; Breast; Radiation; Molecular Breast Imaging; BCT; Dense breast tissue
• Other Study ID Numbers: 09-000455