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

Part of paid clinical trials in Akron, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT05825482
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Arm 1 Partial mastectomy with Savi Scout® localization and shave margins. — PROCEDURE
    Patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. Patients will undergo randomization. With Arm 1 randomization, the surgeons will be instructed to perform a partial mastectomy with routine cavity shave margins using Savi Scout® localization. The lesion will be removed in the routine fashion. The surgeons will use the Savi Scout® to perform routine cavity shave margins by extracting superior, lateral, inferior, medial, anterior, and posterior margins.
  • Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins. — PROCEDURE
    Patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. Patients will undergo randomization. With Arm 2 randomization, the surgeons will be instructed to perform a partial mastectomy with selective margins shave margins using Savi Scout®. The lesion will be removed in the routine fashion. The Savi Scout® localizer will be utilized to determine selective shave margins by examining the same margins on the excised tissue specimen. The surgeon will obtain selective margins if the margin of the tissue specimen is within 1mm of invasive cancer and 2mm within DCIS.

Study Details

This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial mastectomy performed with selective margins and Savi Scout® localization. The primary objective is to determine the difference in positive margin rate between the two methods. The secondary objectives are to determine the differences in the rate of re-excision, volume of tissue extracted and Breast-Q® score between the two methods. It is hypothesized that the Savi Scout® will allow for decreased volume of tissue excised when compared to routine cavity shave margins without any difference in positive margin rate or rate of re-excision.

Key Dates

Start date
Jul 17, 2023
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1
    Partial mastectomy with Savi Scout® localization and routine cavity shave margins
  • Active Comparator: Arm 2
    Partial mastectomy with Savi Scout® localization and selective shave margins.

Primary Outcome Measure

Determine the difference in positive margin rate between the two methods. [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Akron General, Case Comprehensive Cancer CenterAkronOhio44302
Michael McNeal, BSN
[email protected]
330-344-6348
Wendy Catchpole, BS
[email protected]
330-344-6348
Andrew Fenton, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Akron, OH

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Cleveland Clinic Akron General, Case Comprehensive Cancer Center· Akron, OH

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