- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01277276
Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
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 are non-invasive methods measure tissue hemodynamics in real time, direct quantitative information and insights treatment-associated toxicity.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Measurement of brain tissues blood flow
Tidsramme: 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.
|
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Bruce Tromberg, PhD, Beckman Laser Institute University of California Irvine
- Ledende efterforsker: Edward Nelson, MD, Beckman Laser Institute University of California Irvine
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 20086549
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