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Spectral Analysis Probe to Identify Glioblastoma Cells

24 januari 2019 uppdaterad av: University of Oklahoma

Pilot Study Utilizing a Spectral Analysis Probe to Identify Glioblastoma Cells in Patients With Glioblastoma Undergoing Standard Surgical Resection

This is a pilot, observational study to evaluate the intraoperative sensitivity of the Chaos Wand in detecting tumor tissue with glioblastoma disease.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

This is a pilot study to investigate if the Chaos Wand Spectral Diagnosis Probe can be used to identify Glioblastoma (GBM) cancer cells in patients undergoing standard surgical resection. Eligible patients who have consented to the use of the Chaos Wand will be scheduled for surgery as standard cancer care for GBM. During the surgical procedure, the Chaos Wand Spectral Diagnosis Probe will be utilized. Fifteen intraoperative readings and signal recordings of GBM tissue will be taken. The wand will only be used in areas that have already been deemed in need of resection due to GBM disease. Each site identified for spectral analysis will be marked. The wand does not come into contact with the brain at any point during this procedure. Following surgical resection of the GBM tumor, tissue will be collected from the same 15 sites where the Chaos Wand was used. The pathology report will be compared with the results of spectral analysis.

Studietyp

Observationell

Inskrivning (Faktisk)

12

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73104
        • University of Oklahoma Health Sciences Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

The study population includes adult patients from the outpatient neurosurgery clinic or those who have presented through the University of Oklahoma emergency department and have been diagnosed with glioblastoma or are suspected of having glioblastoma based on pre-operative imaging. The Stephenson Cancer Center will not exclude potential subjects from participating in this or any study solely on the basis of ethnic origin or socioeconomic status. Every attempt will be made to enter all eligible patients into this protocol and therefore address the study objectives in a patient population representative of the entire patient population with GBM.

Beskrivning

Inclusion Criteria:

  1. Male or Female and over 18 years of age.
  2. Patients with histologically proven GBM who are newly diagnosed and eligible to undergo surgical treatment or patients who are suspected of having glioblastoma on pre-operative imaging which is subsequently confirmed by histopathology following tumor resection.
  3. Patients must be able to understand and willing to sign the informed consent document.

Exclusion Criteria:

  1. Patients with absence of glioblastoma.
  2. Patients who are not undergoing tumor resection.
  3. Patients who have prior brain radiotherapy
  4. Patients who have prior systemic chemotherapy
  5. Patients who are not willing to sign the informed consent and agree to participate.
  6. Patients who are pregnant or nursing

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean ratio of detecting glioblastoma cancer between the Chaos Wand spectral readings and histopathology as ground truth
Tidsram: 6 months
For participants newly diagnosed with glioblastoma multiforme or patients who are suspected of having glioblastoma on pre-operative imaging who consent to the use of the Chaos Wand during surgery, 15-20 spectral readings will be compared to histopathology as ground truth to measure the sensitivity of the Chaos Wand to detect glioblastoma. For example, if a patient has 15 spectral readings but only 13 are histologically consistent with cancer, then the sensitivity of the wand would be 13/15*100 = 87%. A mean value with standard deviation will be reported across all participants in the study.
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of participants experiencing post-operative intracranial hemorrhage following surgical resection of glioblastoma with use of the Chaos Wand during surgery
Tidsram: Up to 1 month following surgery
For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of intracranial hemorrhage during the post-operative hospital course will be measured.
Up to 1 month following surgery
Number of participants experiencing post-operative ischemic stroke following surgical resection of glioblastoma with use of the Chaos Wand during surgery
Tidsram: Up to 1 month following surgery
For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of ischemic stroke during the post-operative hospital course will be measured.
Up to 1 month following surgery
Number of participants experiencing post-operative surgical site infection following surgical resection of glioblastoma with use of the Chaos Wand during surgery
Tidsram: Up to 1 month following surgery
For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of surgical site infection during the post-operative hospital course will be measured.
Up to 1 month following surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Oklahoma

Utredare

  • Huvudutredare: Michael Sughrue, MD, University of Oklahoma

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

31 oktober 2017

Primärt slutförande (Faktisk)

30 september 2018

Avslutad studie (Faktisk)

30 september 2018

Studieregistreringsdatum

Först inskickad

12 september 2017

Först inskickad som uppfyllde QC-kriterierna

25 september 2017

Första postat (Faktisk)

26 september 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 januari 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 januari 2019

Senast verifierad

1 januari 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 8285

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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