Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
81 participants
INTERVENTIONAL
2016-06-13
2019-11-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cavity Shaving in Breast Conserving Surgery for Breast Cancer Patients
NCT02648802
Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®
NCT05825482
A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients
NCT01452399
Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients
NCT02772731
Shaving as an Safe Alternative to Frozen Section Analysis
NCT07244588
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BCS Arm (breast-conserving surgery - standard of care)
* Defined as partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization
* The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (except for those patients with iodine or seafood allergies or in cases where the goggles are unavailable for use).
* Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of and CSM that are taken.
Breast-conserving surgery (BCS)
BREAST-Q Questionnaire
3-D breast imaging
Using a 3-D breast imaging camera Vectra 3-D XT
Indocyanine green
Intraoperative imaging device
The goggle device is wearable, compact, and battery-operated, and it allows for hands-free operation by the wearer. The goggles provide functional information via a NIR light-emitting diode (LED) integrated within one of the eyepieces, which causes NIR fluorescence excitation of the molecular probes within the surgical field
Peripheral blood draw
-Time of surgery if coordinator is available
CSM Arm (breast-conserving surgery with cavity shave margins)
* Partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization with the addition of additional tissue specimens from all 6 margins (anterior, posterior, superior, inferior, medial, lateral) of the wound cavity if possible. In cases where an additional margin would involve the skin at the anterior margin and/or the pectoral muscle at the posterior margin, only the 4 (or 5) remaining margins should be obtained
* A margin thickness of 1 cm will be the defined goal to establish uniformity among different surgeons and allow for appropriate pathological evaluation
* The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (no iodine or seafood allergies).
* Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of any CSM that are taken.
Breast-conserving surgery (BCS)
Cavity shave margins (CSM)
BREAST-Q Questionnaire
3-D breast imaging
Using a 3-D breast imaging camera Vectra 3-D XT
Indocyanine green
Intraoperative imaging device
The goggle device is wearable, compact, and battery-operated, and it allows for hands-free operation by the wearer. The goggles provide functional information via a NIR light-emitting diode (LED) integrated within one of the eyepieces, which causes NIR fluorescence excitation of the molecular probes within the surgical field
Peripheral blood draw
-Time of surgery if coordinator is available
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Breast-conserving surgery (BCS)
Cavity shave margins (CSM)
BREAST-Q Questionnaire
3-D breast imaging
Using a 3-D breast imaging camera Vectra 3-D XT
Indocyanine green
Intraoperative imaging device
The goggle device is wearable, compact, and battery-operated, and it allows for hands-free operation by the wearer. The goggles provide functional information via a NIR light-emitting diode (LED) integrated within one of the eyepieces, which causes NIR fluorescence excitation of the molecular probes within the surgical field
Peripheral blood draw
-Time of surgery if coordinator is available
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Planning to undergo breast-conserving surgery.
* At least 18 years of age and no more than 85 years of age.
* Female.
* Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion Criteria
* Undergone neoadjuvant chemotherapy.
* History of prior chest radiation therapy.
* Known metastatic disease.
* Pregnant.
* Preference for mastectomy instead of breast-conserving surgery.
* History of ipsilateral breast cancer.
* Goggle assessment substudy: Iodine or seafood allergies.
18 Years
85 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julie Margenthaler, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201506053
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.