HydroMARK Plus Clip for Breast Cancer

Overseen By Quenteeria Mooney

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: No surgery, Age <18 or >90, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to test how successful the retrieval rate of the new HydroMARK Plus Breast Biopsy Site Marker in comparison to HydroMARK.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What makes the HydroMARK Plus Clip treatment unique for breast cancer?

The HydroMARK Plus Clip is unique because it uses a combination of a titanium coil and hydrogel to mark the location of breast tumors, making them easier to detect with ultrasound during surgery, especially after chemotherapy when the tumor may have shrunk or disappeared. ^{1 2 3 4 5}

Research Team

Ceren Yalniz, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for individuals who have undergone a breast biopsy. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.

Inclusion Criteria

I am scheduled for surgery with SCOUT localization and have biopsy clips.

Exclusion Criteria

I am over 90 years old.

Inmates

I have not undergone surgery for my condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of HydroMARK Plus clip during the scout localization procedure

1 week

1 visit (in-person)

Follow-up

Participants are monitored for successful retrieval and surgeon satisfaction

1 week

1 visit (in-person)

Treatment Details

Interventions

• HydroMARK Plus

Trial Overview The study aims to compare the success rates of two different breast biopsy site markers: HydroMARK and the new HydroMARK Plus Clip. The focus is on how often each marker can be successfully retrieved and surgeon satisfaction with its use.

Participant Groups

Group I: Hydromark plus clip placement Experimental Treatment 1 Intervention

Patients with a previously placed HydroMARK T3 coil clip or a clip made by another manufacturer and will have a HydroMARK Plus clip placed during the scout localization procedure for this study. Breast surgeons will perform retrieval and then complete a satisfaction survey to compare the two clips.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Mammotome

Collaborator

Trials

1

Recruited

150+

References

1. Japan pubmed.ncbi.nlm.nih.gov

[A Useful Method of Nipple-Side HydroMARK-Marking before Neoadjuvant Chemotherapy in the Breast Preserving Surgery-A Case Report with pCR of the Triple Negative Breast Cancer]. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a hydrogel based breast biopsy marker (HydroMARK®) as an alternative to wire and radioactive seed localization for non-palpable breast lesions. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Usefulness of tissue marker clips in patients undergoing neoadjuvant chemotherapy for breast cancer. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

[Evaluation of the Small Excision Using a Sonographically Visible Breast Biopsy Marker(HydroMARK®)]. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Using a New Marker Clip System in Breast Cancer: Tumark Vision® Clip - Feasibility Testing in Everyday Clinical Practice. [2022]