Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain

This study has been withdrawn prior to enrollment.
(no participant enrolled)
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01277276
First received: January 12, 2011
Last updated: June 10, 2015
Last verified: June 2015
  Purpose

Currently there is no methodology that can assign a risk of development of chemo brain and thus, studies to understand how and why only some patients develop chemo brain along with studies of potential treatments face major hurdles. This study will define hemodynamic/optical parameters in normal individuals and cancer patients undergoing chemotherapy potentially identifying optical parameters that are associated with the development of chemo brain, leading to new insights into the origin of the chemo brain condition, and importantly potentially identifying parameters that may predict who will develop "chemo brain" in order to directing investigations of therapies.


Condition Intervention
Signs and Symptoms
Device: Diffuse optical spectroscopy and Near infrared spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Measurement of brain tissues blood flow [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Diffuse optical spectroscopy and Near infrared spectroscopy are non-invasive methods measure tissue hemodynamics in real time, direct quantitative information and insights treatment-associated toxicity.


Enrollment: 0
Study Start Date: November 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diagnostic tool
Diffuse optical spectroscopy and Near infrared spectroscopy are non-invasive methods measure tissue hemodynamics in real time, direct quantitative information and insights treatment-associated toxicity.
Device: Diffuse optical spectroscopy and Near infrared spectroscopy
Diffuse optical spectroscopy and Near infrared spectroscopy are non-invasive methods measure tissue hemodynamics in real time, direct quantitative information and insights treatment-associated toxicity.
Other Name: Diffuse optical spectroscopy and Near infrared spectroscopy

Detailed Description:

The researcher can use Non-invasive optical imaging, diffuse optical spectroscopic imaging, measure various tissues and can determine chemo brain symptoms. Near infrared diffuse optical imaging is a real-time, non-invasive technique that measures hemodynamic variations based on changes in hemoglobin oxygenation. Tissue in general and the cerebral cortex surface in particular, are transparent to near infrared light.

Direct optical measurement of cerebral hemodynamic parameters is superior to systemic approaches that infer brain levels of hemoglobin. Optical imaging in conjunction with physiologic maneuvers measures vascular tone and reactivity and may permit early detection of changes in physiology that precede the onset of chemo brain symptoms. Since chemo brain specifically impacts working memory and executive function the optical imaging can measure the frontal cortical areas behind the forehead.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic, community sample

Criteria

Inclusion Criteria:

  • have a histologically proven cancer.
  • Planned initiation of chemotherapy
  • age range between 18-70 years

Exclusion Criteria:

  • have NO a histologically proven cancer.
  • NO planned chemotherapy
  • age less than 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277276

Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Edward Nelson, MD Beckman Laser Institute University of California Irvine
Study Director: Bruce Tromberg, PhD Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Beckman Laser Institute and Medical Center, Edward L. Nelson, M.D, Associate Professor of Medicine, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01277276     History of Changes
Other Study ID Numbers: NIH-LAMMP-2008-6549
Study First Received: January 12, 2011
Last Updated: June 10, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Medical tool

Additional relevant MeSH terms:
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2015