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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Sarcoma

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Trial Information

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


In this study we plan to measure bone and soft tissue sarcoma patients using Diffuse Optical
Spectroscopic Imaging to determine if analogous markers of response exist for these
patients. The first aim of this study is to measure normal volunteers using Diffuse Optical
Spectroscopic Imaging in the anatomic regions where sarcomas typically occur such as the
extremities. This will provide normal optical properties with which to compare sarcoma
measurements. The second aim of this study is to determine the feasibility of measuring
sarcoma patients with Diffuse Optical Spectroscopic Imaging. Since the optical properties
of sarcoma tissue will likely be different from breast tumor tissue, we will measure a small
cohort of patients at baseline (before treatment) to determine typical optical properties
and make any necessary instrument adjustments. The third aim of the study will involve
measuring sarcoma patients using Diffuse Optical Spectroscopic Imaging at multiple
timepoints during their treatment including at baseline, during their first week of
neoadjuvant chemotherapy, at the midpoint of therapy, and before surgical resection.
Additionally, some patients may be measured during their chemotherapy infusions as this
timepoint has shown promising preliminary data in breast cancer patients. Diffuse Optical
Spectroscopic Imaging measurements will be analyzed and compared to overall chemotherapy
response determined by pathology. Additionally, DOSI measurements will be compared to
clinical MRI (or FDG PET/CT) measurements performed at baseline and at posttreatment prior
to surgery according to RECIST/PERCIST criteria. Tumor volume reduction (or tumor metabolic
change) during chemotherapy will be compared to Diffuse Optical Spectroscopic Imaging
measurements. Finally, as a fourth study aim, biopsy specimens from patients will be
analyzed by immunohistochemistry for metabolic, proliferative, and necrotic markers. These
markers will be correlated with optical markers to help further understand the how DOSI can
inform physicians about the tumor biology of sarcomas.


Inclusion Criteria:



- 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

Exclusion Criteria:

- Age less that 18 year old

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas

Outcome Time Frame:

up to 12 months

Safety Issue:

No

Principal Investigator

Bruce Tromberg, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Laser Institute

Authority:

United States: Institutional Review Board

Study ID:

2010-7852

NCT ID:

NCT01263405

Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Sarcoma
  • Sarcoma
  • Osteosarcoma
  • Sarcoma

Name

Location

Beckman Laser InstituteIrvine, California  92612