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Minimally Invasive Imagery With Indocyanine Green (ICG)

16. marts 2018 opdateret af: Sunil Singhall, University of Pennsylvania

A Pilot & Feasibility Study of the Imaging Potential of Indocyanine Green in Subjects Undergoing Minimally Invasive Thoracic Surgery Presenting With Thoracic Nodules

Determine if ICG administered pre-operatively, then imaged intraoperatively using our cameras, will aid in the identification of a suspected thoracic nodules, margins, lymph nodes and satellite nodules during minimally invasive procedures. The investigators intend on enrolling 48 Subjects in this study. The study is focusing on patients presenting with suspected thoracic cancers who are considered to be good minimally invasive surgical candidates

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

According to the World Health Organization, lung cancer is the most common cause of cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide annually as of 2004.

Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismal 53% for Stage I and 32% for Stage II (1). The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery it would be possible for us to improve the rates of recurrence free patients and thus overall survival.

The use of an ICG probe will allow for the operating field and lung tissue to be observed in real-time.

ICG has been used in the clinical settings since 1957. There is a wealth of data available attesting to the safety of this drug injected at its current clinically indicated dosing level. ICG has been shown to preferentially uptake in esophageal tumors as opposed to surrounding epithelial lumen after one minute of IV exposure (2). Additionally, the same group reported being able to better characterize the vascularization of the tumor to further clarify the invasiveness of the cancer. ICG usage has been shown to be safe in a similar clinical setting by the Gotoh group, who used ICG to detect and characterize bullous and emphysematous lesion of the lung in video assisted thoracoscopic surgeries (VATS) with Infrared Thoracoscopy that were not previously detectable by white light (3).

The currently proposed trial is a single center, open-label pilot/observational cohort study. Patients with a diagnosis of resectable thoracic nodule/mass who are presumed to be resectable via minimally invasive surgery as determined by pre-operative assessment at the Hospital of the University of Pennsylvania will be included.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hospital of the University of Pennsylvania

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

Beskrivelse

Inclusion Criteria:

  1. Adult patients over 18 years of age
  2. Patients presenting with a thoracic nodule presumed to be resectable cancer on pre-operative assessment
  3. Good minimally invasive operative candidates as determined by a thoracic oncology multidisciplinary team
  4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

  1. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
  2. Subjects with a history of iodide allergies

  3. At-risk patient populations

    1. Homeless patients
    2. Patients with drug or alcohol dependence
    3. Children and neonates
    4. Patients unable to participate in the consent process

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Indocyanine Green
Dosage calculated by weight of individual, 5mg/kg.
Medicin: Indocyanine Green
Infusion of ICG 24 hours prior to surgery
Andre navne:
  • ICG

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ability of imaging system to detect expression of ICG in nodule/mass (i.e. tumor) and discern uptake of dye by tumor
Tidsramme: 36 months
Detected with imaging probe during minimally invasive procedure
36 months

Sekundære resultatmål

Resultatmål
Tidsramme
Incidence rates of all adverse events, treatment-emergent adverse events, and adverse device events from time of ICG administration through participants' first, post-operative appointment with surgeon
Tidsramme: 36 Months
36 Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pennsylvania

Efterforskere

  • Ledende efterforsker: Sunil Singhal, MD, University of Pennsylvania

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. november 2014

Primær færdiggørelse (Faktiske)

1. november 2016

Studieafslutning (Faktiske)

1. november 2016

Datoer for studieregistrering

Først indsendt

1. december 2015

Først indsendt, der opfyldte QC-kriterier

1. december 2015

Først opslået (Skøn)

3. december 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. marts 2018

Sidst verificeret

1. marts 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 820766

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 .

Kliniske forsøg med Neoplasmer

Kliniske forsøg med Indocyanine Green

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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