RECRUITING

Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy

Quick Facts

Study Start:2019-07-17

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02926729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patient scheduled to undergo lumpectomy for breast cancer at BIDMC. * Core needle biopsy revealing invasive breast cancer or DCIS. * Female. * 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* Patient scheduled to undergo lumpectomy for breast cancer at BIDMC.
* Core needle biopsy revealing invasive breast cancer or DCIS.
* Female.
* 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.

* 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.

Contacts and Locations

Study Contact

James Connolly, MD

CONTACT

617-667-4344

jconnoll@bidmc.harvard.edu

Principal Investigator

James Connolly, MD

PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

James Connolly, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-17

Study Completion Date2025-08

Study Record Updates

Study Start Date2019-07-17

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

Breast Cancer

Additional Relevant MeSH Terms

Breast Cancer