Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI

NCT02725658 | Withdrawn

• 1 other identifier: 20152355
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this research study is to help us learn if an experimental imaging device called Diffuse Optical Spectroscopic Imaging (DOSI) can monitor tumor shrinkage during chemotherapy treatment and can predict if the tumor will respond to chemotherapy before the end of the treatment. This study will also help us understand the biological reason for how DOSI works.

Conditions

Breast Tumor

Keywords

Neoadjuvant Therapy; Diffuse Optical Spectroscopic Imaging; DOSI; Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (5)

• Concentration of oxy-hemoglobin (HbO2), in blood.

  through study completion, an average of 3 years

• Concentration of deoxy-hemoglobin (HHb) in blood.

  through study completion, an average of 3 years

• Concentration of total hemoglobin in blood.

  through study completion, an average of 3 years

• Water content of tissue (%)

  through study completion, an average of 3 years

• Bulk lipid in tissue (%)

  through study completion, an average of 3 years

Study Arms (1)

DOSI

OTHER

Device: DOSI

Interventions

DOSI DEVICE

Breast tissue properties scanning

Also known as: Diffuse Optical Spectroscopy

DOSI

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females between the ages of 21 and 80. Specific to Study part #1
• Diagnosed with a Breast Imaging-Reporting and Data System score of 4 or higher breast abnormality greater than 1cm in size Specific to Study part #2
• Enrolled in study part #1
• Diagnosed with histologically-proven invasive breast cancer
• Prescribed neoadjuvant chemotherapy for breast cancer

You may not qualify if:

• Pregnant
• Unable to give written, informed consent.

Sponsors & Collaborators

• Beckman Laser Institute and Medical Center: lead
• Beckman Laser Institute University of California Irvine: collaborator
• University of California, San Francisco: collaborator

Study Sites (4)

Pacific Breast Care Clinic

Costa Mesa, California, 92627, United States

Location

Beckman Laser Institute University of California Irvine

Irvine, California, 92612, United States

Location

University of California, Irvine Medical Center

Irvine, California, 92612, United States

Location

University of California San Francisco

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Bruce J Tromberg, PhD

  Beckman Laser Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Bruce Tromberg, PhD, Director Beckman Laser Institute and Medical Clinic, Professor, Departments of Biomedical Engineering and Surgery

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: April 1, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)