Optical Spectroscopy in Evaluating Tumor Margins in Patients Who Have Undergone Surgery for Breast Tumors

NCT00625417 | Completed

• 4 other identifiers: CDR0000587230P30CA068485VU-VICC-BRE-0718VU-VICC-060554
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Diagnostic procedures, such as optical spectroscopy, may help learn the extent of disease and allow doctors to plan better treatment. PURPOSE: This phase I trial is studying optical spectroscopy to see how well it works in evaluating tumor margins in patients who have undergone surgery for breast cancer.

Conditions

Breast Cancer

Keywords

male breast cancer; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (2)

• Development of a non-invasive detection tool that evaluates breast tumor margins in real-time to guide tumor resection during partial mastectomy procedures

  A 3-D scanner that can scan a breast lump will be developed so that breast margin may be evaluated with Raman spectroscopy

  1 year

• Evaluated optical spectroscopy in differentiating breast tumor or tumor margins from normal breast tissue

  This device will be tested in patient specimens intra-operatively before going to pathology and compared to histopathology to evaluate the ability of the device to detect margin up to 2 mm deep

  2 years

Study Arms (1)

Optical spectroscopy on tumor margins

EXPERIMENTAL

Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery

Procedure: breast biopsy; Procedure: histopathologic examination; Procedure: light-scattering spectroscopy; Procedure: therapeutic conventional surgery

Interventions

breast biopsy PROCEDURE

Optical spectroscopy on tumor margins

histopathologic examination PROCEDURE

Optical spectroscopy on tumor margins

light-scattering spectroscopy PROCEDURE

Optical spectroscopy on tumor margins

therapeutic conventional surgery PROCEDURE

Optical spectroscopy on tumor margins

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Vanderbilt University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anita Mahadevan-Jansen, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Biomedical Engineering

Model Details: Optical spectroscopy is applied to evaluate tumor margins in consenting patients who undergo surgery for breast tumors

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: February 28, 2008
• Study Start: August 1, 2006
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)