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

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Mayo Clinic

Status

Completed

Conditions

Breast Cancer

Treatments

Device: Molecular Breast Imaging

Study type

Observational

Funder types

Other

Identifiers

NCT01027767
09-000455

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

23 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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