Breast Neoplasm Female, Ultrasound Therapy; Complications
Conditions
Keywords
axillary lymph node, biopsy clip, biopsy marker, ultrasound
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 with pathology-proven metastatic axillary lymph nodes. Per standard of care, a biopsy marker will have already been associated with the positive lymph node. 10 such patients scheduled for surgery at Mayo Clinic Rochester, MN with Dr. James Jakub will be enrolled. Preoperative radioactive seed localization will proceed as usual, but the marker will be additionally loaded with the seed into the needle using standard protocol. Before surgery, ultrasound will be performed to evaluate the marker.
Interventions
DEVICEResearch Marker
The research marker is a cylindrical-shaped marker made of an FDA-approved material that can be seen by ultrasound.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound detectability | Time of placement to surgical resection. | Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conspicuity compared to conventional biopsy markers and radioactive seeds | Time of placement to surgical resection. | To compare conspicuity of marker with that of conventional biopsy markers and I-125 localization seeds. |
Countries
United States
Outcome results
None listed