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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027767
• Other study ID #: 09-000455
• Status: Completed
• Phase: N/A
• First received: December 8, 2009
• Last updated: February 13, 2013
• Start date: May 2009
• Est. completion date: September 2012

Study information

• Verified date: February 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Molecular Breast Imaging
Molecular Breast Imaging

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States,