Breast CancerNCT05825482
Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®
A study testing Arm 1 Partial mastectomy with Savi Scout® localization and shave margins. and Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins. in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Arm 1 Partial mastectomy with Savi Scout® localization and shave margins. and Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years and older, and
- With Clinical stage I-II invasive breast cancer, or Stage 0 DCIS, and
- That have been diagnosed by means of core needle biopsy appropriate for breast conserving therapy, and
- Present to Cleveland Clinic Akron General.
- Subjects must have pathologically confirmed breast carcinoma or ductal carcinoma in situ.
- Performance status: ECOG 0-1
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
- Patients may have received or may be receiving endocrine therapy.
Who cannot join
- Men
- Pregnant women
- Patients who have received neoadjuvant chemotherapy for current cancer diagnosis.
- Patients with current diagnosis of synchronous bilateral breast cancer. (A diagnosis of breast cancer at least one year prior to current cancer diagnosis is acceptable.)
- Patients < 18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Akron General, Case Comprehensive Cancer Center
Akron, Ohio, 44302
About this study
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.
Read the detailed description
Over a period of 24 months, this study will recruit 204 women 18 years and older with stage I-II breast cancer or stage 0 DCIS that have been diagnosed by core needle biopsy and are planning to receive breast conserving surgery.
After obtaining consent, the patient will be asked to complete the Breast-Q® questionnaire which should take about 10-15 minutes for the patient to complete. The patient will then be randomized in a 1:1 fashion to:
Arm 1: Partial mastectomy with Savi Scout® localization and routine cavity shave margins
Arm 2: Partial mastectomy with Savi Scout® localization and selective shave margins.
Arm 1 and 2 patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. The surgeons will be instructed to perform a partial mastectomy with routine cavity shave margins using Savi Scout® or partial mastectomy with selective margins using Savi Scout®. The lesion will be removed in the routine fashion. For patients in arm 1, the surgeons will use the Savi Scout® to perform routine cavity shave margins by extracting superior, lateral, inferior, medial, anterior, and posterior margins. For patients in arm 2, 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. All surgeons participating in the study will undergo an educational session to ensure consistency.
Tissue specimens will be processed per hospital policy and sectioned for gross evaluation. Tissue specimens will be assessed by the pathologists at Cleveland Clinic Akron General. This simulates typical pathology review. Positive margin rate is a categorical variable and will be reviewed by pathology board certified physicians and thus should have minimal interpersonal variation.
At the postoperative visit, the patient will be asked to complete another Breast-Q® questionnaire.
- Conditions
- Breast Cancer
- Being tested
- Arm 1 Partial mastectomy with Savi Scout® localization and shave margins., Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins.
- Keywords
- Breast Cancer, Savi Scout, Shave margin, Selective margin, Breast-Q
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 Partial mastectomy with Savi Scout® localization and shave margins.Procedure or surgery
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 or surgery
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 group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Partial mastectomy with Savi Scout® localization and routine cavity shave margins Receives: Procedure: Arm 1 Partial mastectomy with Savi Scout® localization and shave margins. |
| Arm 2 | Active comparator | Partial mastectomy with Savi Scout® localization and selective shave margins. Receives: Procedure: Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the difference in positive margin rate between the two methods.
The primary objective is to determine the difference in positive margin rate between the two methods.
Measured: 24 months
Secondary outcomes (3)
Difference in the rate of re-excision between the two methods.
Determine the difference in the rate of re-excision between the two methods.
Measured: 24 months
Difference in the volume of tissue extracted between the two methods.
Determine the difference in the volume of tissue extracted between the two methods.
Measured: 24 months
Difference in the BREAST-Q® Version 2.0 Breast Conserving Therapy Module Pre- and Postoperative Scales
Determine the difference in the Breast-Q® scores between the two methods. Scores range from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start17 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Fenton, M.D., Principal investigator, Cleveland Clinic Akron General, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825482
- Sponsor's protocol ID
- CASE5122
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®
- ClinicalTrials.gov ID
- NCT05825482
- Acronym / sponsor ID
- CASE5122
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Savi Scout, Shave margin, Selective margin, Breast-Q
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Over a period of 24 months, this study will recruit 204 women 18 years and older with stage I-II breast cancer or stage 0 DCIS that have been diagnosed by core needle biopsy and are planning to receive breast conserving surgery.
After obtaining consent, the patient will be asked to complete the Breast-Q® questionnaire which should take about 10-15 minutes for the patient to complete. The patient will then be randomized in a 1:1 fashion to:
Arm 1: Partial mastectomy with Savi Scout® localization and routine cavity shave margins
Arm 2: Partial mastectomy with Savi Scout® localization and selective shave margins.
Arm 1 and 2 patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. The surgeons will be instructed to perform a partial mastectomy with routine cavity shave margins using Savi Scout® or partial mastectomy with selective margins using Savi Scout®. The lesion will be removed in the routine fashion. For patients in arm 1, the surgeons will use the Savi Scout® to perform routine cavity shave margins by extracting superior, lateral, inferior, medial, anterior, and posterior margins. For patients in arm 2, 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. All surgeons participating in the study will undergo an educational session to ensure consistency.
Tissue specimens will be processed per hospital policy and sectioned for gross evaluation. Tissue specimens will be assessed by the pathologists at Cleveland Clinic Akron General. This simulates typical pathology review. Positive margin rate is a categorical variable and will be reviewed by pathology board certified physicians and thus should have minimal interpersonal variation.
At the postoperative visit, the patient will be asked to complete another Breast-Q® questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Procedure: Arm 1 Partial mastectomy with Savi Scout® localization and shave margins.Partial mastectomy with Savi Scout® localization and routine cavity shave margins |
| Arm 2 | Active comparator | Procedure: Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins.Partial mastectomy with Savi Scout® localization and selective shave margins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women 18 years and older, and
- With Clinical stage I-II invasive breast cancer, or Stage 0 DCIS, and
- That have been diagnosed by means of core needle biopsy appropriate for breast conserving therapy, and
- Present to Cleveland Clinic Akron General.
- Subjects must have pathologically confirmed breast carcinoma or ductal carcinoma in situ.
Key exclusion criteria (5 listed)
- Men
- Pregnant women
- Patients who have received neoadjuvant chemotherapy for current cancer diagnosis.
- Patients with current diagnosis of synchronous bilateral breast cancer. (A diagnosis of breast cancer at least one year prior to current cancer diagnosis is acceptable.)
- Patients < 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1 Partial mastectomy with Savi Scout® localization and shave margins.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. | Procedure or surgery | Arm 1 |
| Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins.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. | Procedure or surgery | Arm 2 |
Primary outcome
Determine the difference in positive margin rate between the two methods.
Time frame: 24 months
The primary objective is to determine the difference in positive margin rate between the two methods.
3 secondary outcomes
Difference in the rate of re-excision between the two methods.
Time frame: 24 months
Difference in the volume of tissue extracted between the two methods.
Time frame: 24 months
Difference in the BREAST-Q® Version 2.0 Breast Conserving Therapy Module Pre- and Postoperative Scales
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Fenton, M.D. principal investigator
Cleveland Clinic Akron General, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1 Partial mastectomy with Savi Scout® localization and shave margins. and Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins. in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the difference in positive margin rate between the two methods. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.