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

Sponsor
University of California, Irvine (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01277276
Collaborator
Beckman Laser Institute University of California Irvine (Other)
0
51

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: 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.

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain
Study Start Date :
Nov 1, 2008
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Measurement of brain tissues blood flow [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None 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
Other Study ID Numbers:
  • NIH-LAMMP-2008-6549
First Posted:
Jan 14, 2011
Last Update Posted:
Feb 10, 2017
Last Verified:
Feb 1, 2017
Keywords provided by Beckman Laser Institute and Medical Center, Edward L. Nelson, M.D, Associate Professor of Medicine, University of California, Irvine

Study Results

No Results Posted as of Feb 10, 2017