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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicole P. Sandhu, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01027767
First received: December 8, 2009
Last updated: February 13, 2013
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Device: Molecular Breast Imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Effect of Surgery and Radiation Therapy on Tc-99M Sestamibi Uptake Patterns in Molecular Breast Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Enrollment: 23
Study Start Date: May 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women who are seen in the Mayo Clinic Breast Clinic

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027767

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Nicole Sandhu, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Nicole P. Sandhu, MD, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01027767     History of Changes
Other Study ID Numbers: 09-000455
Study First Received: December 8, 2009
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Breast
MBI
Molecular
Molecular Breast Imaging
 Dense breast tissue
Surgery
Radiation
BCT

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013