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Procedure

Arm 1 for Breast Cancer

N/A

Recruiting

Led By Andrew Fenton, M.D.

Research Sponsored by Cleveland Clinic Akron General

Eligibility Criteria Checklist

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

Must have

Subjects must have pathologically confirmed breast carcinoma or ductal carcinoma in situ

Performance status: ECOG 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial compares two methods of partial mastectomy for breast cancer. One method involves routine cavity shave margins and Savi Scout® localization, while the other involves selective margins and Savi Scout® localization.

Who is the study for?

This trial is for women aged 18 or older with early-stage breast cancer (stage I-II) or stage 0 DCIS, diagnosed via core needle biopsy and suitable for breast-conserving therapy. Participants must be patients at Cleveland Clinic Akron General.Check my eligibility

What is being tested?

The study compares two surgical techniques in partial mastectomy: one uses routine cavity shave margins with Savi Scout® localization, while the other uses selective shave margins with the same localization tool. The goal is to see which method results in fewer positive margin rates and less tissue removal without increasing re-surgery needs.See study design

What are the potential side effects?

While specific side effects are not listed, typical risks of partial mastectomy may include pain, swelling, bleeding, infection risk at the surgery site, changes in breast shape or size, and possible anesthesia complications.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with breast cancer or ductal carcinoma in situ.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I am a woman over 18 with early-stage breast cancer or DCIS, eligible for breast-conserving therapy, and I am seeing a doctor at Cleveland Clinic Akron General.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Determine the difference in positive margin rate between the two methods.

Secondary outcome measures

Difference in the BREAST-Q® Version 2.0 Breast Conserving Therapy Module Pre- and Postoperative Scales

Difference in the rate of re-excision between the two methods.

Difference in the volume of tissue extracted between the two methods.

Trial Design

2Treatment groups

Active Control

Group I: Arm 1Active Control1 Intervention

Partial mastectomy with Savi Scout® localization and routine cavity shave margins

Group II: Arm 2Active Control1 Intervention

Partial mastectomy with Savi Scout® localization and selective shave margins.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cleveland Clinic Akron GeneralLead Sponsor

7 Previous Clinical Trials

278 Total Patients Enrolled

Andrew Fenton, M.D.Principal InvestigatorCleveland Clinic Akron General

Frequently Asked Questions

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

Are individuals currently able to apply and participate in this ongoing research study?

"As per clinicaltrials.gov, this current trial is actively in search of eligible participants. The original posting date for the study was July 17th, 2023, with the most recent update dated February 5th, 2024."

Answered by AI

What is the current number of participants being recruited for this research endeavor?

"Indeed, information available on clinicaltrials.gov confirms the ongoing recruitment efforts for this research. The trial was initially posted on July 17th, 2023 and last revised on February 5th, 2024. Recruitment aims to enroll a total of 204 participants at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®

2023. "Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05825482.