What is the mechanism of action of this treatment?

The SAVI Reflector and SCOUT Surgical Guidance System utilize infrared (IR) and radar wave localization to accurately identify and target breast lesions. These systems involve implanting a small reflector near the lesion, which is then detected intraoperatively using a handheld probe that emits and receives IR and radar signals. This precise localization is crucial for breast lesion patients as it allows for targeted excision of the lesion, minimizing damage to surrounding healthy tissue and improving surgical outcomes. Accurate lesion localization reduces the likelihood of incomplete removal, which can decrease the risk of recurrence and the need for additional surgeries.

What side effects are associated with this type of intervention?

The SAVI Reflector and SCOUT Surgical Guidance System are used for the localization and excision of breast lesions. Common side effects associated with these treatments include localized pain, bruising, and swelling at the site of the reflector implantation. There may also be a risk of infection, bleeding, and discomfort during the procedure. Additionally, patients might experience temporary changes in breast sensation. These side effects are generally mild and manageable, but it is important for patients to discuss potential risks with their healthcare provider.

What prior FDA approvals exist?

The SCOUT Surgical Guidance System, approved by the FDA in 2014 and for long-term use in 2017, utilizes infrared and radar wave localization to precisely target breast lesions. This system includes an implantable reflector and a hand-held probe that provides real-time localization during surgery. Similarly, the SAVI Reflector, another nonradioactive device, uses electromagnetic waves for lesion localization. These technologies represent advancements in the precise surgical management of breast lesions, improving the accuracy and outcomes of breast-conserving surgeries.

What other types of research exist?

Promising alternatives to the SAVI Reflector and SCOUT Surgical Guidance System for breast lesion localization include: 1) Robotic SPECT systems, which provide high accuracy and augmented-reality image guidance for precise localization. 2) Advanced infrared navigation systems, which have shown feasibility in tracking and localizing lesions with high precision. 3) Time-variant seasonal autoregressive (TVSAR) models for real-time tumor motion tracking, offering sub-millimeter accuracy and improved dynamic beam tracking for moving tumors.

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Device

SAVI Scout for Breast Lesions

Phase < 1

Recruiting

Led By Tanya Moseley, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unifocal, histologically-proven T0-T3, N0-1 invasive breast cancer at the time of mid-chemotherapy imaging if receiving neoadjuvant therapy

Be older than 18 years old

Must not have

Inflammatory breast carcinoma

Distant metastasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a device that helps surgeons accurately locate and remove breast tumors. It uses a small implant that sends signals to a handheld tool, guiding the surgeon during surgery. The target group is patients with breast tumors needing precise removal.

Who is the study for?

This trial is for adults with a confirmed diagnosis of unifocal invasive breast cancer or highly suspicious breast lesions. It's suitable for those undergoing mid-chemotherapy imaging if they're receiving neoadjuvant therapy. People with distant metastasis, certain concurrent trial participations, active cardiac implants, inflammatory breast carcinoma, or nickel allergy cannot participate.

What is being tested?

The SAVI Scout system is being tested to help locate and remove suspicious breast lesions without using radiation. It involves implanting a small reflector into the lesion area and then using a handheld device during surgery to find it by sound and visual cues.

What are the potential side effects?

Potential side effects may include discomfort at the site where the reflector is implanted, possible allergic reactions in individuals sensitive to materials like nickel contained in the device, and general surgical risks associated with lesion removal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My breast cancer is in early stages and confirmed by a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My breast cancer is inflammatory.

Select...

My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SAVI Scout®Experimental Treatment1 Intervention

marker is accurately placed in the breast tumor

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The SAVI Reflector and SCOUT Surgical Guidance System utilize infrared (IR) and radar wave localization to accurately identify and target breast lesions. These systems involve implanting a small reflector near the lesion, which is then detected intraoperatively using a handheld probe that emits and receives IR and radar signals. This precise localization is crucial for breast lesion patients as it allows for targeted excision of the lesion, minimizing damage to surrounding healthy tissue and improving surgical outcomes. Accurate lesion localization reduces the likelihood of incomplete removal, which can decrease the risk of recurrence and the need for additional surgeries.

[Radiation therapy after mastectomy--interdisciplinary consensus puts and end to a controversy. German Society of Senology].Targeted intra-operative radiotherapy (Targit): an innovative method of treatment for early breast cancer.