nonlinear microscopy imaging of excised surgical margins for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Beth Israel Deaconess Medical Center, Boston, MA
Breast Cancer+1 More
nonlinear microscopy imaging of excised surgical margins - Device
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a new imaging instrument can help surgeons determine whether they have removed all of the cancerous tissue during lumpectomy surgery.

See full description

Eligible Conditions

  • Breast Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether nonlinear microscopy imaging of excised surgical margins will improve 1 primary outcome in patients with Breast Cancer. Measurement will happen over the course of 2 years.

2 years
Rate of recommendation for repeat surgery on postoperative histopathology

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
1 of 2
Experimental
1 of 2
Active Control
Experimental Treatment

This trial requires 98 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nonlinear Microscopy Imaging Of Excised Surgical Margins is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental
Device
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.
Control
Procedure
Standard lumpectomy without nonlinear microscopy imaging.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
J. C.
Prof. James Connolly, MD
Dana-Farber Cancer Institute

Closest Location

Beth Israel Deaconess Medical Center - Boston, MA

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

What are the signs of breast cancer?

"Signs of breast cancer include nipple discharge and lump sensations. In younger women, other signs of breast cancer include nipple redness, skin changes and a lump." - Anonymous Online Contributor

Unverified Answer

Can breast cancer be cured?

"With modern treatments, the survival rates are very high in [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). The five-year survival (i.e., cure rate) of breast cancer has improved significantly during the 20-year period that has elapsed since the establishment of the modern treatment technologies described above (see Treatment section). However, the disease often recurs, and these recurrences are incurable. Although the five-year survival rate is high for breast cancer, it is lower for other major cancers. For these cancers, the five-year survival rate is often around 50% (i.e., it can be cure 50% of the time)." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"In the UK, 1 in 15 women is diagnosed with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) at some point in their life. They can be identified by symptoms such as a lump in the breast or nipple or the thickening of the nipple. The majority of breast cancer cases are either early stage or non-metastatic. Only 10% end up requiring immediate mastectomy and nearly one third will need lumpectomy only. The diagnosis of breast cancer can lead to significant psychological and physical distress. The effects can last beyond breast cancer treatments and into the years after treatment. Breast cancer can have a long term effect on a woman's mood and mental health. Men with breast cancer are more likely to have depressed mood than healthy men." - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"Most [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s in the NHS are related to the screening program for breast cancer since the start of the 1990s. This is true both in breast density as measured by mammography and the prevalence, incidence and mortality of breast cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"It can be difficult to diagnose a case of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) early, since symptoms are sometimes not noticed until the woman is almost incapacitated by advanced cancer. As long as it has not spread elsewhere in the body, treatment is surgically curable (removing the lump through a skin incision, followed by a mastectomy). People with stage 3 breast cancer, though, often have tumors that have spread (metastasized) to remote sites such as the lungs. The most common form is anthracycline therapy. A few newer agents are available, such as the anti-HER2 anti-neuronal growth factor rituximab and other biological agents." - Anonymous Online Contributor

Unverified Answer

How many people get breast cancer a year in the United States?

"About 10% of all cancers in the United States are breast cancers. A total of 36,070 women in the US are diagnosed with breast cancer every year. This makes up about 14 cancers per 100,000 women in the US. Most women with breast cancer have diagnosed with estrogen receptor positive breast cancer; 22% to have diagnosed with estrogen receptor negative breast cancer. The five-year survival rate was 79%, while the five-year survival rate was 74.9%, respectively. These 5-year survival rates are higher than the rates in the rest of the world." - Anonymous Online Contributor

Unverified Answer

How does nonlinear microscopy imaging of excised surgical margins work?

"LMT can be used to characterize tumour margins in a tissue microarray (TMA) sample. The algorithm presented here uses a simple and intuitive method to define a specific region in a TMA sample as the "hotspot" for assessment of tumour/normal-like/vacant areas. A "rule-based" image quality criterion of ≤4.2 was used to quantify microscopic changes and define a region centered on the hotspot to perform feature-detection." - Anonymous Online Contributor

Unverified Answer

Has nonlinear microscopy imaging of excised surgical margins proven to be more effective than a placebo?

"The use of nonlinear microscopy imaging to analyze the excised margins of mastectomies for cancer may identify more recurrence and may have a role in improving patient management." - Anonymous Online Contributor

Unverified Answer

What is the latest research for breast cancer?

"These studies are critical because they provide information for patient care and for clinicians working in breast cancer management. Additional studies that may not be included in this review are underway and might shed more light on the topic." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating breast cancer?

"Most of what's currently being researched, whether it is through chemoprevention, the use of aromatase inhibitors to reduce estrogen hormone levels, or by other means, is directed towards treating the primary cancer (i.e. removing the lump) rather than any metastasizing (i.e. spread) cancer. There has been little research on how to reduce risks of metastases (secondary cancer) which account for as many deaths in women as the initial cancer. This research, both in the lab and in clinical cohorts, would likely yield useful results for patients." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving nonlinear microscopy imaging of excised surgical margins?

"In the future, we hope that more imaging methods can usefully supplement surgical pathology to aid both the surgeon and the pathologist in their ability to evaluate surgical margins." - Anonymous Online Contributor

Unverified Answer

How quickly does breast cancer spread?

"This is a relatively high estimate based on the assumption that metastases occur in a linear pattern from any site of initial cancer spread. The high degree of variability between metastatic sites suggests a more complex spread pattern, with different sites of metastatic spread and variable numbers of metastatic sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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