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

NCT ID: NCT01277276

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2013-02-28

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.

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.

Conditions

Signs and Symptoms

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Diffuse optical spectroscopy and Near infrared spectroscopy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Beckman Laser Institute and Medical Center

Edward L. Nelson, M.D, Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward Nelson, MD

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute University of California Irvine

Bruce Tromberg, PhD

Role: STUDY_DIRECTOR

Beckman Laser Institute University of California Irvine

Other Identifiers

20086549

Identifier Type: -

Identifier Source: org_study_id