Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging

NCT01257932 | Withdrawn DMC

• 1 other identifier: 20107812
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have developed imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy, both prior to and as early as possible during the course of treatment. The efficacy and practicality of conventional imaging approaches in the neoadjuvant chemotherapy setting varies and identifies the need for alternate functional imaging strategies. Diffuse optical spectroscopic imaging is an experimental imaging method that allows patients to be followed from baseline through treatment and surgery with a cost-effective, bedside, handheld scanning probe. The researcher evaluates a harmonized diffuse optical spectroscopic imaging technology platform that has been standardized for neoadjuvant chemotherapy monitoring. Diffuse optical spectroscopic imaging is an academic research platform that is non-invasive. Studies will be performed in five clinical sites on approximately 60 neoadjuvant chemotherapy patients.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic Tool Breast Cancer Response to Neoadjuvant Chemotherapy

  Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy

  up to 12 months

Study Arms (1)

Diagnostic Tool

Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy

Device: Diffuse Optical Spectroscopy Imaging

Interventions

Diffuse Optical Spectroscopy Imaging DEVICE

Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy

Diagnostic Tool

Eligibility Criteria

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

Study Population

primary care clinic and community sample

You may qualify if:

• Female, 18 years of age or older, non pregnant or nursing.
• Diagnosis of breast cancer and will be receiving chemo therapy treatments

You may not qualify if:

• years of age or younger, pregnant or nursing.
• Previous treatment including chemo therapy, radiation, surgery, and hormone therapy.
• Previous diagnosis with other form of cancer.

Sponsors & Collaborators

• University of California, Irvine: lead
• American College of Radiology Imaging Network: collaborator
• Massachusetts General Hospital: collaborator
• University of Pennsylvania: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• University of San Francisco: collaborator
• M.D. Anderson Cancer Center: collaborator
• Boston University: collaborator
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (1)

Beckman Laser Institute

Irvine, California, 92612, 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 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: December 8, 2010
• First Posted: December 10, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

US (1)