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

NCT01027767 | Completed

• 1 other identifier: 09-000455
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast; MBI; Molecular; Molecular Breast Imaging; Dense breast tissue; Surgery; Radiation; BCT

Study Arms (2)

Surgery/Radiation Arm

Patients that have had surgery along with radiation therapy

Device: Molecular Breast Imaging

Surgery Arm

Patients that have had surgery of a benign lesion.

Device: Molecular Breast Imaging

Interventions

Molecular Breast Imaging DEVICE

Molecular Breast Imaging

Surgery Arm; Surgery/Radiation Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who are seen in the Mayo Clinic Breast Clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, 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 Officials

• Nicole Sandhu, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 15, 2013

Record last verified: 2012-02

Locations

US (1)