Status:
COMPLETED
Mayo Designed Soft Tissue Ultrasound-Detectable Marker
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Neoplasm Female
Ultrasound Therapy; Complications
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Researchers are trying to determine if the Mayo marker is easily seen with ultrasound making it easier, faster, and more accurate for preoperative localization of the biopsied positive lymph node.
Detailed Description
Nonrandomized clinical trial to evaluate the Mayo-designed marker for ultrasound conspicuity at the time of preoperative ultrasound-guided localization. Study participants are breast cancer patients ...
Eligibility Criteria
Inclusion
- Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node
- Surgical management involves preoperative radioactive seed localization of a previously identified positive axillary lymph node
- Surgery will be performed by Dr. James Jakub at Mayo Clinic Rochester, MN
- Radioactive seed localization of an axillary lymph node.
- No contraception is necessary or required.
- English speaking
Exclusion
- Scheduled for only radioactive seed localizations in the breast (as opposed to axilla)
- Are pregnant; although the twinkling marker is made of material widely used in orthopedic procedures, and hence, has an excellent safety profile, the investigators want to exclude the population of pregnant patients in this phase 0 clinical trial.
Key Trial Info
Start Date :
November 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04674852
Start Date
November 2 2020
End Date
April 7 2022
Last Update
January 20 2023
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905