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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This study has been withdrawn prior to enrollment.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: August 5, 2015
Last verified: August 2015

January 12, 2011
August 5, 2015
November 2008
February 2013   (final data collection date for primary outcome measure)
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.
chemotherapy side effects [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01277276 on ClinicalTrials.gov Archive Site
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Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain
Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
primary care clinic, community sample
Signs and Symptoms
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.
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.
Intervention: Device: Diffuse optical spectroscopy and Near infrared spectroscopy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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United States
 
NCT01277276
NIH-LAMMP-2008-6549
No
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Beckman Laser Institute and Medical Center, University of California, Irvine
University of California, Irvine
Beckman Laser Institute University of California Irvine
Principal Investigator: Edward Nelson, MD Beckman Laser Institute University of California Irvine
Study Director: Bruce Tromberg, PhD Beckman Laser Institute University of California Irvine
University of California, Irvine
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP