98 Participants Needed

Nonlinear Microscopy for Surgical Evaluation in Breast Cancer

JC
Overseen ByJames Connolly, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude those who have had any systemic neoadjuvant (preoperative) therapy between the core biopsy and lumpectomy.

What data supports the effectiveness of the treatment Nonlinear Microscopy Imaging of Excised Surgical Margins in breast cancer surgery?

Research shows that Nonlinear Microscopy (NLM) can rapidly and accurately assess surgical margins during breast cancer surgery, reducing the need for repeat surgeries. Studies demonstrate that NLM achieves high diagnostic accuracy, with sensitivity and specificity rates over 90%, and can be performed quickly on fresh specimens, making it a promising tool for real-time surgical evaluation.12345

Is nonlinear microscopy safe for use in humans?

Nonlinear microscopy has been used safely in studies for assessing breast and rectal cancer tissues, showing high diagnostic accuracy and no adverse effects reported. It allows for real-time imaging without the need for traditional tissue processing, and the imaging agents used are removed to undetectable levels after processing.12345

How is Nonlinear Microscopy Imaging of Excised Surgical Margins different from other treatments for breast cancer?

Nonlinear Microscopy Imaging is unique because it allows for real-time, detailed imaging of surgical margins during breast cancer surgery without the need for traditional tissue processing, which can delay results. This method uses advanced imaging techniques to quickly assess whether cancerous tissue remains, potentially reducing the need for repeat surgeries.12467

What is the purpose of this trial?

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.

Research Team

JC

James Connolly, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I am at least 21 years old.
Ability to understand and the willingness to sign a written informed consent document
I am scheduled for a lumpectomy at BIDMC for breast cancer.
See 7 more

Exclusion Criteria

I cannot undergo radiation therapy due to health reasons.
I have cancer or DCIS where I've had surgery before.
I received treatment before my breast surgery.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Imaging

Participants undergo standard lumpectomy with or without nonlinear microscopy imaging of excised surgical margins

1 day
1 visit (in-person)

Postoperative Pathologic Evaluation

Standard pathologic evaluation of the specimen is performed some days after lumpectomy to decide on the need for additional surgery

1-2 weeks

Follow-up

Participants are monitored for recommendations on additional surgery based on postoperative histopathology

2 years

Treatment Details

Interventions

  • Nonlinear Microscopy Imaging of Excised Surgical Margins
  • Standard Lumpectomy without Nonlinear Microscopy Imaging
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials
872
Recruited
12,930,000+

Dana-Farber Cancer Institute

Collaborator

Trials
1,128
Recruited
382,000+

Massachusetts Institute of Technology

Collaborator

Trials
104
Recruited
12,810,000+

Findings from Research

A new multiscale, real-time microscope using nonlinear microscopy (NLM) allows for rapid and comprehensive imaging of surgical margins during breast cancer surgery, potentially reducing the need for repeat surgeries due to close or positive margins.
This NLM technique provides cellular resolution imaging without the need for freezing and cryo-sectioning, making it faster and more efficient than traditional methods like frozen section analysis, which could improve intraoperative decision-making.
Multiscale nonlinear microscopy and widefield white light imaging enables rapid histological imaging of surgical specimen margins.Giacomelli, MG., Yoshitake, T., Cahill, LC., et al.[2020]
Multimodal nonlinear optical microscopy can effectively monitor therapeutic responses in rectal cancer, identifying key histopathological changes such as tumor regression and inflammatory responses without the need for labeling.
This technique shows promise as a real-time, in vivo imaging method that could help clinicians tailor treatment strategies by providing immediate insights into the effectiveness of neoadjuvant therapy.
Monitoring neoadjuvant therapy responses in rectal cancer using multimodal nonlinear optical microscopy.Li, LH., Chen, ZF., Wang, XF., et al.[2019]
A new method using acridine orange and sulforhodamine 101 for real-time histological evaluation during breast cancer surgeries allows for rapid assessment of surgical margins, potentially reducing the need for repeat surgeries due to close or positive margins.
This technique, validated against standard histology, can image tissue up to 100 μm deep and preserves important diagnostic features, making it a promising tool for improving surgical outcomes in breast cancer treatment.
Rapid virtual hematoxylin and eosin histology of breast tissue specimens using a compact fluorescence nonlinear microscope.Cahill, LC., Giacomelli, MG., Yoshitake, T., et al.[2023]

References

Multiscale nonlinear microscopy and widefield white light imaging enables rapid histological imaging of surgical specimen margins. [2020]
Monitoring neoadjuvant therapy responses in rectal cancer using multimodal nonlinear optical microscopy. [2019]
Rapid virtual hematoxylin and eosin histology of breast tissue specimens using a compact fluorescence nonlinear microscope. [2023]
Assessment of breast pathologies using nonlinear microscopy. [2022]
Label-free detection of residual breast cancer after neoadjuvant chemotherapy using biomedical multiphoton microscopy. [2020]
Intraoperative Label-Free Multimodal Nonlinear Optical Imaging for Point-of-Procedure Cancer Diagnostics. [2021]
Second and third harmonic generation microscopy visualizes key structural components in fresh unprocessed healthy human breast tissue. [2021]
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