Predicting Pathological Response Within the 1st Week of Chemotherapy Using Diffuse Optical Spectroscopic Imaging

NCT01277263 | Withdrawn DMC

• 1 other identifier: 20107789
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

Women with Breast Cancer who do not respond to chemotherapy may undergo months of treatment with little or no change in tumor size or overall outcome. The Researchers have demonstrated a previously undescribed "metabolic flare" response observed very early in neoadjuvant treatment in breast cancer patients. The research can determine that this flare is predictive of overall therapy response and is due to both an inflammatory reaction and cell death induced by cytotoxic therapy.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• improve treatment prognosis for breast cancer patients

  The proposed research plan has the ability to significantly impact breast cancer research and treatment

  12 weeks

Interventions

Diffuse Optical Spectroscopy Imaging DEVICE

Monitoring Breast Cancer during chemo therapy

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will be selected from an outpatient population of the Cancer Center Clinic, Beckman Laser Medical Clinic of University of California, Irvine and UCI Pacific Breast Care. Subjects with the requisite diagnosis of breast cancer will be candidates for enrollment.

You may qualify if:

• Female, not pregnant, not breastfeeding
• greater than 21 years of age but less than 75 years of age
• will be receiving neoadjuvant chemotherapy for breast cancer as prescribed by their oncologist

You may not qualify if:

• Under 21 year of age
• Female pregnant or breastfeeding

Sponsors & Collaborators

• University of California, Irvine: lead
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (3)

Pacific Breast Care Medical Clinic

Costa Mesa, California, 92627, United States

Location

Beckman Laser Institute

Irvine, California, 92612, United States

Location

Chao Family Comprehensive Cancer Center, UCIMC

Orange, California, 92868, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

C-Protein serum

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Bruce Tromberg, PhD

  Beckman Laser Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL 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 12, 2011
• First Posted: January 14, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

US (3)