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NCT07087691 · ClinicalTrials.gov registry record · NA

Efficacy of OneMark Device in Identifying Breast Cancer for Surgery and Surveillance

A NA study of Breast Cancer, sponsored by University of California, San Diego.

Recruiting
Registry status
NA
Development phase
60
Enrollment target
1
Study location

NCT07087691: Recruiting NA study of Breast Cancer, sponsored by University of California, San Diego.

NCT07087691 is a NA study of Breast Cancer that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 60 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07087691, a NA study of Breast Cancer, is actively recruiting participants, sponsored by University of California, San Diego.

RECRUITING
Registry status
NA
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

The goal of this research is to study a localization device for breast cancer called OneMark. This device will be studied in breast cancer surgery and during surveillance in patients being monitored for breast cancer. The main questions the study aims to answer are: Can surgeons visualize the OneMark device during breast cancer surgery better than a standard of care visualization device? Can radiologists visualize the OneMark device over time during breast cancer surveillance in patients with low or high density breast tissue? Participants will undergo breast cancer surgery or surveillance as required for their regular care. For patients undergoing surgery, the device will be implanted ahead of surgery. For patients in surveillance, the device will be implanted during biopsy and visibility of the device will be assessed by radiologists after 1, 3, and 6 months, and optionally after 12 months. Surgeons will complete a questionnaire at every surgery on the visibility of the OneMark device and the standard of care visualization device. Radiologists will complete a questionnaire after 1, 3, 6 months (and optionally after 12 months) after implantations in the patients in the surveillance program.

Primary Outcome

Visibility rankings of OneMark marker and SAVI SCOUT on a 4-point scale. Grade 0: no visibility; Grade 1: uncertain visibility; Grade 2: some visibility; Grade 3: definite visibility.

Conditions Studied

Interventions

  • DEVICE OneMark device

Study Locations (1)

California

  • University of California, San Diego - La Jolla

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-12-22
Est. Completion 2028-09
Phase NA
University of California, San Diego

775 total trials

What NCT07087691 shows while recruiting

NCT07087691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which OneMark device is the first listed.

NCT07087691 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT07087691 about?

NCT07087691 is a clinical study titled "Efficacy of OneMark Device in Identifying Breast Cancer for Surgery and Surveillance". The goal of this research is to study a localization device for breast cancer called OneMark. This device will be studied in breast cancer surgery and during surveillance in patients being monitored for breast cancer. The main questions the study aims to answer are: Can surgeons visualize the OneM...

What is the current status of trial NCT07087691?

This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-12-22. Estimated completion is 2028-09.

What conditions does trial NCT07087691 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT07087691?

The interventions under investigation include: OneMark device (DEVICE).

Who is sponsoring clinical trial NCT07087691?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07087691 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07087691's enrollment target sits among peer trials

60 736th of 1224 higher than 468 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07087691, the US trial registry maintained by the National Library of Medicine. NCT07087691 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.