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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the retrieval success of a new breast biopsy site marker, HydroMARK Plus, with an existing marker, HydroMARK. The focus is on enhancing retrieval success during breast cancer surgeries. Participants will receive a HydroMARK Plus clip during their procedure. The study seeks patients who already have a biopsy clip and are scheduled for surgery using SCOUT localization. As an unphased trial, it offers patients the chance to contribute to advancements in surgical techniques for breast cancer.

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 prior data suggests that the HydroMARK Plus Breast Biopsy Site Marker is safe?

Research has shown that HydroMARK Plus markers are safe for people. These markers are MR-conditional, meaning they can be safely used during MRI scans. This provides reassurance for those requiring regular imaging tests. The HydroMARK Plus marker is designed to remain in the body unless the surrounding tissue requires surgical removal. While specific safety data from human trials for HydroMARK Plus is not available, it is based on the existing HydroMARK technology already used in medical settings. This suggests a level of safety, as the original marker is well-established. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The HydroMARK Plus clip is unique because it offers an innovative way to improve the precision and effectiveness of breast cancer surgeries. Unlike traditional clips used to mark tumor locations, the HydroMARK Plus clip is designed to be more easily identifiable during procedures, potentially aiding surgeons in accurate retrieval and reducing surgery time. Researchers are excited about this treatment because it could lead to better surgical outcomes and higher satisfaction for both surgeons and patients, making the process less stressful and more efficient.

What evidence suggests that the HydroMARK Plus clip is effective for breast cancer?

Research has shown that the HydroMARK Plus improves doctors' ability to locate biopsy site markers during breast cancer procedures. It enhances the original HydroMARK by adding features that help maintain its position. This marker swells to more than twice its original size, becoming visible on imaging within 24 hours and remaining visible for up to 12 months. These enhancements assist doctors in locating the marker more easily during follow-up procedures, which is crucial for planning effective treatment. The new design is expected to offer greater reliability than previous versions. During the scout localization procedure, participants in this trial will have a HydroMARK Plus clip placed, allowing breast surgeons to compare it with previously placed clips. ^{1 4 6 7 8}

Who Is on the Research Team?

Ceren Yalniz, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. prnewswire.com prnewswire.com/apac/news-releases/mammotome-launches-the-hydromark-plus-breast-biopsy-site-marker-an-innovation-for-tissue-marker-displacement-301905522.html

Mammotome Launches the HydroMARK™ Plus Breast ... The hydrogel-based carrier hydrates more than 200% original size and becomes strikingly anechoic within 24 hours, and lasts up to 12 months, ...

2. mammotome.com mammotome.com/us/en/products/breast-biopsy-markers/hydromark-plus

HydroMARK™ Plus Breast Biopsy Site Marker | Mammotome The HydroMARK™ Plus marker features the same great benefits of the original HydroMARK™ markers, with added features to alleviate displacement, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06294574?locStr=United+States&country=United+States

Improved Successful Retrieval Rate of HydroMARK Plus ... 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. Detailed ...

4. mammotome.com mammotome.com/us/en/products/breast-biopsy-markers/hydromark

HydroMARK TM Breast Biopsy Site Marker Studies have shown that visibility can last up to 12 months in some patients.1. Can you use HydroMARK TM markers in lymph nodes? The HydroMARK ...

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/470903

Improved Successful Retrieval Rate of HydroMARK Plus ... 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.

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=19773547&pc=NEU

HYDROMARK BREAST BIOPSY SITE MARKER The hydromark biopsy site marker is a permanent implant and is not intended to be removed unless the marked tissue is determined to require surgical removal.

7. mammotome.com mammotome.com/assets/product-documents/markers/hydromark-hydromark-plus-direct-puncture-tech-specs.pdf

Technical Specifications MRI Visibility Compatibility. Implanted HydroMARK™ and HydroMARK™ Plus markers are MR-conditional, meaning the patient may be safely scanned during MR imaging.

8. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20864127&pc=NEU

HYDROMARK BREAST BIOPSY SITE MARKER - CE The hydromark biopsy site marker is a permanent implant and is not intended to be removed unless the marked tissue is determined to require surgical removal.