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Recruiting

NCT Number: NCT07686250

Evaluation and Outcomes of SAVI Scout MD for Localized Breast Surgery

The purpose of the study is to evaluate how precise the SAVI Scout MD is and how easy it is for surgeons to use during surgery. The SAVI Scout MD system uses tiny radar reflectors instead of wires, can be placed days or weeks before surgery, helps surgeons find the cancer more precisely and may lower the chance of needing a second surgery.

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Brian Czerniecki, MD

SUB_INVESTIGATOR

Christine Laronga, MD

SUB_INVESTIGATOR

David Detz, MD

SUB_INVESTIGATOR

John Kiluk, MD

SUB_INVESTIGATOR

Laura Kruper, MD

SUB_INVESTIGATOR

Marie Lee, MD

PRINCIPAL_INVESTIGATOR

Melissa Mallory, MD

SUB_INVESTIGATOR

Nazanin Khakpour, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult females who are 18 years of age or older at time of signing informed consent will be eligible.
  • Must have ability to comprehend and the willingness to sign written informed consent for study participation.
  • Patients must have at least one sonographically, mammographically, or MRI identifiable in-breast malignancy and consent to undergo a surgical resection requiring bracketed localization (more than one localizing marker) at Moffitt Cancer Center. Mammographically or sonographically visible biopsy clips may be used as a localizing target.

Exclusion criteria

  • Patients undergoing mastectomy for resection of the targeted lesion.
  • Planned excision of multiple separate sites in the ipsilateral breast.
  • Inability to undergo surgery at Moffitt Cancer Center.

Treatment and study plan

SAVI Scout MD system

Device

Implantable radar reflector system allowing placement of multiple uniquely identifiable localizers for intraoperative tumor localization.

Primary outcomes

  1. Successful Operation Rate (SOR)

    Time frame: Up to 6 weeks.

    Proportion of patients achieving complete tumor resection with negative surgical margins ("no tumor on ink" or ≥2 mm for DCIS).

Study contacts

Contact information is provided by the study sponsor or research team.

Diane Tendoh

CONTACT

[email protected]

813-745-4979

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Merit Medical

Registry information

Official study title

Clinical Evaluation and Outcomes of Multi-signal SAVI Scout (Scout MD) Localized Breast Conserving Surgery

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 7, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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