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Device

SAVI Scout® for Breast Lesions

Q: What is the current number of individuals taking part in this experiment?

<p>Indeed, clinicaltrials.gov reports that this trial is actively seeking participants and was initially posted on April 11th 2022. The last update to the study was made November 3rd of the same year. Currently, one site requires 100 applicants for entry into the trial.</p>

Q: Is this investigation still enrolling participants?

<p>Clinicaltrials.gov affirms that recruitment for the study is underway, with initial posting occurring on April 11th 2022 and subsequent editing taking place on November 3rd of that same year.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial is to assess the safety and effectiveness of the SAVI Scout for surgical guidance during breast cancer surgery.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain

Trial Design

1Treatment groups

Experimental Treatment

Group I: SAVI Scout®Experimental Treatment1 Intervention

marker is accurately placed in the breast tumor

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,246 Total Patients Enrolled

1 Trials studying Breast Lesions

120 Patients Enrolled for Breast Lesions

Tanya Moseley, MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

SAVI Scout® (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05118295 — Phase < 1

Breast Lesions Research Study Groups: SAVI Scout®

Breast Lesions Clinical Trial 2023: SAVI Scout® Highlights & Side Effects. Trial Name: NCT05118295 — Phase < 1

SAVI Scout® (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05118295 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals taking part in this experiment?

"Indeed, clinicaltrials.gov reports that this trial is actively seeking participants and was initially posted on April 11th 2022. The last update to the study was made November 3rd of the same year. Currently, one site requires 100 applicants for entry into the trial."

Answered by AI

Is this investigation still enrolling participants?

"Clinicaltrials.gov affirms that recruitment for the study is underway, with initial posting occurring on April 11th 2022 and subsequent editing taking place on November 3rd of that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single Step Lesion Annotation and Localization of Suspicious Breast Lesions

2022. "Single Step Lesion Annotation and Localization of Suspicious Breast Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05118295.