Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas Using Diffuse Optical Spectroscopic Imaging

NCT01263405 | Completed DMC

• 2 other identifiers: 20107852Department Fund
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the ability of a specific imaging method, termed Diffuse Optical Spectroscopic Imaging, to provide metabolic and functional information which can be used to predict overall response to preoperative (neoadjuvant) chemotherapy in patients with sarcomas. Sarcoma patients face comparatively poor response rates to chemotherapy and early, non-invasive indications of response could provide physicians with the information necessary to make evidence-based changes in treatment strategies. Patients who do not demonstrate early signs of response would be spared the unnecessary side-effects of an ineffective chemotherapy regimen, and could either be switched to a different regimen or undergo surgery

Conditions

Sarcoma

Keywords

Sarcoma

Outcome Measures

Primary Outcomes (1)

• Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas

  up to 12 months

Study Arms (2)

Normal

normal volunteers without sarcoma

Sarcoma

Sarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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:

• Any subjects with no current or previous history of sarcoma are eligible to be a normal volunteer
• Any subject with a sarcoma neoplasm is eligible to be measured for aim 2 of the study
• Only patients undergoing neoadjuvant chemotherapy for sarcoma are eligible for Aim 3 of the study

You may not qualify if:

• Age less that 18 year old

Sponsors & Collaborators

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

Study Sites (1)

Beckman Laser Institute

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Bruce Tromberg, PhD

  Beckman Laser Institute

  PRINCIPAL INVESTIGATOR

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 16, 2010
• First Posted: December 20, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

US (1)