- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01263405
Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas Using Diffuse Optical Spectroscopic Imaging
28. oktober 2022 opdateret af: Beckman Laser Institute and Medical Center, University of California, Irvine
The purpose of this study is to determine the ability of a specific imaging method, termed Diffuse Optical Spectroscopic Imaging, to provide metabolic and functional information which can be used to predict overall response to preoperative (neoadjuvant) chemotherapy in patients with sarcomas.
Sarcoma patients face comparatively poor response rates to chemotherapy and early, non-invasive indications of response could provide physicians with the information necessary to make evidence-based changes in treatment strategies.
Patients who do not demonstrate early signs of response would be spared the unnecessary side-effects of an ineffective chemotherapy regimen, and could either be switched to a different regimen or undergo surgery
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
In this study we plan to measure bone and soft tissue sarcoma patients using Diffuse Optical Spectroscopic Imaging to determine if analogous markers of response exist for these patients.
The first aim of this study is to measure normal volunteers using Diffuse Optical Spectroscopic Imaging in the anatomic regions where sarcomas typically occur such as the extremities.
This will provide normal optical properties with which to compare sarcoma measurements.
The second aim of this study is to determine the feasibility of measuring sarcoma patients with Diffuse Optical Spectroscopic Imaging.
Since the optical properties of sarcoma tissue will likely be different from breast tumor tissue, we will measure a small cohort of patients at baseline (before treatment) to determine typical optical properties and make any necessary instrument adjustments.
The third aim of the study will involve measuring sarcoma patients using Diffuse Optical Spectroscopic Imaging at multiple timepoints during their treatment including at baseline, during their first week of neoadjuvant chemotherapy, at the midpoint of therapy, and before surgical resection.
Additionally, some patients may be measured during their chemotherapy infusions as this timepoint has shown promising preliminary data in breast cancer patients.
Diffuse Optical Spectroscopic Imaging measurements will be analyzed and compared to overall chemotherapy response determined by pathology.
Additionally, DOSI measurements will be compared to clinical MRI (or FDG PET/CT) measurements performed at baseline and at posttreatment prior to surgery according to RECIST/PERCIST criteria.
Tumor volume reduction (or tumor metabolic change) during chemotherapy will be compared to Diffuse Optical Spectroscopic Imaging measurements.
Finally, as a fourth study aim, biopsy specimens from patients will be analyzed by immunohistochemistry for metabolic, proliferative, and necrotic markers.
These markers will be correlated with optical markers to help further understand the how DOSI can inform physicians about the tumor biology of sarcomas.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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California
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Irvine, California, Forenede Stater, 92612
- Beckman Laser Institute
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
primary care clinic and community sample
Beskrivelse
Inclusion Criteria:
- Any subjects with no current or previous history of sarcoma are eligible to be a normal volunteer
- Any subject with a sarcoma neoplasm is eligible to be measured for aim 2 of the study
- Only patients undergoing neoadjuvant chemotherapy for sarcoma are eligible for Aim 3 of the study
Exclusion Criteria:
- Age less that 18 year old
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Normal
normal volunteers without sarcoma
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Sarcoma
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas
Tidsramme: up to 12 months
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up to 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Bruce Tromberg, PhD, Beckman Laser Institute
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2010
Primær færdiggørelse (Faktiske)
1. oktober 2014
Studieafslutning (Faktiske)
1. oktober 2014
Datoer for studieregistrering
Først indsendt
16. december 2010
Først indsendt, der opfyldte QC-kriterier
17. december 2010
Først opslået (Skøn)
20. december 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. november 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. oktober 2022
Sidst verificeret
1. oktober 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20107852
- Department Fund (Andet bevillings-/finansieringsnummer: Department Fund)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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