NCT02926729 · Beth Israel Deaconess Medical Center
Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
What this study is about
This research is studying a new investigative imaging instrument called a nonlinear microscope (NLM). A nonlinear microscope can produce images similar to an ordinary pathologist's microscope, but without first processing tissue to make slides.
View original scientific description
This research is studying a new investigative imaging instrument called a nonlinear microscope (NLM). A nonlinear microscope can produce images similar to an ordinary pathologist's microscope, but without first processing tissue to make slides. This study will determine if a NLM can be used to evaluate tissue during lumpectomy surgery for breast cancer in order to reduce the probability that standard pathologic examination of the specimen after the end of the operation will find close or positive margins, thus possibly requiring the patient to have additional breast surgery.
Interventions
DEVICE
nonlinear microscopy imaging of excised surgical margins
Following standard lumpectomy excision, excised tissue will be imaged with NLM. If invasive cancer or ductal carcinoma in situ (DCIS) is detected on or close to the margin, additional excision may be performed. Following surgery, final margins will be evaluated using paraffin embedded histopathology as per standard procedure. Paraffin embedded histopathology will be used to make a final margin determination.
PROCEDURE
standard lumpectomy without nonlinear microscopy imaging
Lumpectomy with postoperative paraffin embedded histopathology to make a final margin determination.
Primary outcome measures
Rate of recommendation for repeat surgery on postoperative histopathology
Time frame: 2 years
The percent of patients in each arm who have a recommendation for additional surgery because of near or involved margins as a result of the standard postoperative histopathologic review (by a pathologist blinded to whether the patient was on the experimental or control arm).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient scheduled to undergo lumpectomy for breast cancer at BIDMC.
- Core needle biopsy revealing invasive breast cancer or DCIS.
- Minimum age of 21 years.
- Eligible for breast conserving surgery, lumpectomy and radiation.
- Estrogen receptor positive (ER+) on core needle biopsy, or if estrogen receptor negative (ER-), have evaluable estrogen receptor status with positive internal control on core biopsy.
- Progesterone receptor positive (PR+) on core needle biopsy if biopsy indicates invasive cancer, or if progesterone receptor negative (PR-) on biopsy indicating invasive cancer, have evaluable progesterone receptor status with positive internal control on core biopsy.
- HER2 IHC and/or FISH ordered on core biopsy, if biopsy indicates invasive cancer.
- Oncotype DX or other genetic assay performed on core biopsy or not requested.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- Contraindicated for radiation therapy.
- Pregnancy. (Pregnant women will be excluded from this study because radiation therapy is contraindicated during pregnancy.)
- Current invasive cancer or DCIS at the site of a previous surgery.
- Any systemic neoadjuvant (or preoperative) therapy between the core biopsy and lumpectomy.
- Involvement in another therapeutic trial for breast cancer at Dana Farber or elsewhere.
- Risk of poor cosmetic outcome after initial lumpectomy and possible additional excision, as assessed by a study surgeon.
- Recommendation for mastectomy based on radiology.
- Patients that have complex DCIS as indicated on radiology, which would require excising a large tissue volume.
- No or equivocal ER, PR or HER2 testing performed prior to surgery if biopsy indicates invasive cancer.
- No or equivocal ER testing performed prior to surgery if biopsy indicates ductal carcinoma in situ.
Where
- Boston, Massachusetts
Collaborators
Massachusetts Institute of Technology, Dana-Farber Cancer Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 9, 2024 · Source of record for eligibility and locations