Recruiting
Phase 2

SAVI Scout MD

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT07686250

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SAVI Scout MD system

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Study ID

NCT07686250

Start date

Jul, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

37 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SAVI Scout MD Localization

Participants undergo image-guided placement of multiple Scout MD reflectors followed by breast-conserving surgery using the device for intraoperative localization.

Interventions

SAVI Scout MD system

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

Primary outcome measure

  • Successful Operation Rate (SOR) [ Time Frame: Up to 6 weeks. ]

Central Contacts and Locations

Central contacts

Diane Tendoh

813-745-4979Diane.Tendoh@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Marie Lee, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-07-30.