MedDataX Logo

An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients

NCT ID: NCT00734955

Last Updated: 2020-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. We have also shown that data collection and processing from a single point on the tissue specimen requires less than 5 seconds. In addition, the technique is easily adaptable to provide sensing depths that are required for breast margin assessment. The goal of the work proposed in this protocol is to test the sensitivity and specificity of an optical assay system developed by our group, for intra operative assessment of breast tumor margins.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

NCT01372631

Breast Cancer
COMPLETED NA

Fast Spectral Imaging Device for Tumor Margin Mapping

NCT01107080

Breast Cancer
COMPLETED

Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)

NCT02313116

Breast Cancer
SUSPENDED

Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)

NCT01699867

Breast Cancer
COMPLETED

MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery

NCT00749931

Breast Cancer
COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reduction Mammoplasty

Patients undergoing reduction mammoplasty

Group Type EXPERIMENTAL

49-channel optical spectrometer

Intervention Type DEVICE

Mastectomy

Patients undergoing mastectomy

Group Type EXPERIMENTAL

49-channel optical spectrometer

Intervention Type DEVICE

Lumpectomy

Patients undergoing a lumpectomy

Group Type EXPERIMENTAL

49-channel optical spectrometer

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

49-channel optical spectrometer

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of Breast Cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nimmi Ramanujam, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01EB011574-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00007857

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Intra-operative Detection of Positive Margins in Breast Surgery
NCT06977698 RECRUITING
Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy
NCT00734838 COMPLETED NA
Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
NCT02926729 RECRUITING NA
Survey of Optical Values of the Breast Using Radiation-Free Pressure-Free Optical Scanning
NCT00671385 UNKNOWN
Breast Study to Determine the Ability of Non-Invasive Optical Transillumination Spectroscopy to Predict Breast Density.
NCT00188682 COMPLETED
Optical Detection of Malignancy During Percutaneous Interventions
NCT01730365 COMPLETED
Measurements of Breast Tissue Optical Properties
NCT00540540 WITHDRAWN
Clinical Explorative Optical Breast Investigations
NCT06857669 RECRUITING NA
Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
NCT02033486 UNKNOWN NA
Performance Assessment of a First Generation Breast Microwave Imaging System: Study of Breast Abnormalities Detection
NCT02566499 WITHDRAWN NA
Evaluation of Breast Cancer Surgical Margins Using Optical Spectroscopy
NCT00214292 COMPLETED NA
Optical Spectroscopy in Evaluating Tumor Margins in Patients Who Have Undergone Surgery for Breast Tumors
NCT00625417 COMPLETED NA
Nipple Secretion Samples in Detecting Breast Cancer in Patients and Healthy Participants Undergoing Breast Cancer Screening, Breast Diagnostic Studies, or Treatment for Benign Breast Disease
NCT00813878 TERMINATED
The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease
NCT01687790 COMPLETED NA
NIR Fluorescent Molecular Probe for the Identification of Breast Tissue
NCT05708144 COMPLETED NA
Efficacy of OneMark Device in Identifying Breast Cancer for Surgery and Surveillance
NCT07087691 NOT_YET_RECRUITING NA
In Vitro Detection of Tissue Abnormality
NCT01209182 COMPLETED NA
Study of Monochromatic X-ray Mammography System
NCT07219797 NOT_YET_RECRUITING NA
MarginProbe 2.0 Data Collection Protocol
NCT05377229 COMPLETED
Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)
NCT00500383 COMPLETED
Real Time Optical Coherence Tomography (OCT) of Human Tissue
NCT01506700 TERMINATED
Breast Study to Learn More About the Application of Optical Transillumination Measurements to Assess Breast Cancer Risk and to Potentially Detect the Presence of Breast Cancer.
NCT00188721 COMPLETED
Using Diagnostic Tools to Stage Breast Cancer
NCT00367666 ACTIVE_NOT_RECRUITING NA
MarginProbe® System U.S. Post-Approval Study
NCT02406599 UNKNOWN NA
Trop2-targeting NIR-II Molecular Probe for Breast Cancer Precise Surgery
NCT06713681 RECRUITING