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Mayo Designed Soft Tissue Ultrasound-Detectable Marker

Primary Purpose

Breast Neoplasm Female, Ultrasound Therapy; Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Research Marker
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Breast Neoplasm Female focused on measuring axillary lymph node, biopsy clip, biopsy marker, ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Marking cN+ nodes

Arm Description

These patients have already undergone neoadjuvant chemotherapy for locally advanced breast cancer with metastasis to the axillary lymph nodes. During standard of care needle-directed I-125 seed localization, the research marker will also be deployed through the same needle. Ultrasound detection of the marker will be compared to conventional biopsy markers and the I-25 seed.

Outcomes

Primary Outcome Measures

Ultrasound detectability
Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization.

Secondary Outcome Measures

Conspicuity compared to conventional biopsy markers and radioactive seeds
To compare conspicuity of marker with that of conventional biopsy markers and I-125 localization seeds.

Full Information

First Posted
December 14, 2020
Last Updated
January 19, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04674852
Brief Title
Mayo Designed Soft Tissue Ultrasound-Detectable Marker
Official Title
A Mayo-Designed Nonmetallic, Ultrasound-Detectable Marker for Metastatic Axillary Lymph Nodes in Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
July 26, 2021 (Actual)
Study Completion Date
April 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female, Ultrasound Therapy; Complications
Keywords
axillary lymph node, biopsy clip, biopsy marker, ultrasound

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Marking cN+ nodes
Arm Type
Other
Arm Description
These patients have already undergone neoadjuvant chemotherapy for locally advanced breast cancer with metastasis to the axillary lymph nodes. During standard of care needle-directed I-125 seed localization, the research marker will also be deployed through the same needle. Ultrasound detection of the marker will be compared to conventional biopsy markers and the I-25 seed.
Intervention Type
Device
Intervention Name(s)
Research Marker
Intervention Description
The research marker is a cylindrical-shaped marker made of an FDA-approved material that can be seen by ultrasound.
Primary Outcome Measure Information:
Title
Ultrasound detectability
Description
Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization.
Time Frame
Time of placement to surgical resection.
Secondary Outcome Measure Information:
Title
Conspicuity compared to conventional biopsy markers and radioactive seeds
Description
To compare conspicuity of marker with that of conventional biopsy markers and I-125 localization seeds.
Time Frame
Time of placement to surgical resection.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Lee, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36367449
Citation
Jakub JW, Hesley GK, Larson NB, Yaszemski MJ, Lee Miller A 2nd, Greenleaf JF, Urban MW, Lee CU. Ultrasonographic Detection and Surgical Retrieval of a Nonmetallic Twinkle Marker in Breast Cancer: Pilot Study. Radiol Imaging Cancer. 2022 Nov;4(6):e220053. doi: 10.1148/rycan.220053.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Mayo Designed Soft Tissue Ultrasound-Detectable Marker

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