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Imaging

Nonlinear Microscopy for Surgical Evaluation in Breast Cancer

N/A

Recruiting

Led By James Connolly, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Minimum age of 21 years

Patient scheduled to undergo lumpectomy for breast cancer at BIDMC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is studying a new microscope to see if it can help evaluate breast cancer during surgery to avoid the need for more surgery later.

Who is the study for?

This trial is for women over 21 with breast cancer who are scheduled for lumpectomy at BIDMC. They must have certain hormone receptor statuses confirmed, be eligible for surgery and radiation, and not pregnant. Those with previous surgeries at the cancer site or on neoadjuvant therapy can't join.Check my eligibility

What is being tested?

The study compares using a new imaging tool called nonlinear microscope (NLM) during lumpectomy to standard practice without NLM. The goal is to see if NLM can better ensure all cancer is removed during the initial surgery.See study design

What are the potential side effects?

Since this trial involves an imaging technique rather than a drug, traditional side effects like those seen with medications are not expected. However, there may be unforeseen risks associated with the use of new technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 21 years old.

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I am scheduled for a lumpectomy at BIDMC for breast cancer.

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My breast cancer is estrogen receptor positive, or if negative, it has been evaluated and confirmed with a biopsy.

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I have had a genetic test on a biopsy or it was not needed.

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My biopsy for invasive cancer included HER2 testing.

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I am a candidate for surgery to remove part of my breast and radiation.

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My biopsy showed I have invasive breast cancer or DCIS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of recommendation for repeat surgery on postoperative histopathology

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExperimentalExperimental Treatment1 Intervention

Standard lumpectomy followed by nonlinear microscopy imaging of excised surgical margins. If invasive cancer or DCIS at or close to the margin is detected, additional excision may be performed.

Group II: ControlActive Control1 Intervention

Standard lumpectomy without nonlinear microscopy imaging.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,850 Total Patients Enrolled

141 Trials studying Breast Cancer

22,519 Patients Enrolled for Breast Cancer

Massachusetts Institute of TechnologyOTHER

97 Previous Clinical Trials

12,729,889 Total Patients Enrolled

James Connolly, MDPrincipal Investigator - Beth Israel Deaconess Medical Center

Medical School - Washington University, St. Louis, Doctor of Medicine

Harvard University, Brigham and Women's Hospital, Residency in Internal Medicine

Media Library

Nonlinear Microscopy Imaging of Excised Surgical Margins (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT02926729 — N/A

Breast Cancer Research Study Groups: Experimental, Control

Breast Cancer Clinical Trial 2023: Nonlinear Microscopy Imaging of Excised Surgical Margins Highlights & Side Effects. Trial Name: NCT02926729 — N/A

Nonlinear Microscopy Imaging of Excised Surgical Margins (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02926729 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any participation opportunities currently available for this research?

"Affirmative. According to the details listed online at clinicaltrials.gov, this research project is in an active recruitment phase as of August 9th 2022, having been first posted on July 17th 2019. The trial demands 98 participants from a single medical centre."

Answered by AI

To what extent has recruitment been successful for this research endeavor?

"Affirmative. Clinicaltrials.gov states that this clinical trial, initiated on July 17th 2019 and updated August 9th 2022, is actively enrolling 98 patients at a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

James Connolly, MD 2019. "Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02926729.

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