Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Use of the EnLightTM and LightPathTM Imaging Systems in Gastrointestinal Tumour Surgery (CLIO)

25. januar 2017 opdateret af: Lightpoint Medical Limited

Evaluation of the Use of Intra-operative Molecular Imaging With BetaScope and in Vitro Measurement With LightPath Specimen Analyser Devices in Gastrointestinal Tumour Surgery

This study will evaluate the performance of the EnLightTM and LightPathTM Imaging Systems in detecting tumour lesions in patients with gastric, pancreas, bile duct or duodenal cancer.

EnLightTM will be used to detect positron emission and the LightPathTM system to detect Cerenkov Luminescence. Both are emitted by the Positron Emission Tomography (PET) agent.

The study will also evaluate the patient safety and radiation safety of the EnLightTM, and the safety for the device operators and surgical staff of the LightPathTM Imaging System.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a pilot study that is prospective, open-label, single-centre in nature in patients with gastric, pancreas, bile duct or duodenal cancer in whom tumour excision surgery is indicated.

Patients who give written informed consent will be screened for the study (Visit 1). Patients will undergo a positron emission tomography (PET) whole body scan. Screening assessments, including the PET scan, must be performed no less than 60 days before surgery and may be performed on the day of surgery.

On the day of surgery (Visit 2), subject's blood glucose level will be measured. Subjects with a blood glucose level < 12 mmol/l will receive an intravenous injection of 2-5 Mega Becquerel/kg (MBq/kg), up to a maximum 300 MBq of fluorine-18 fluorodeoxyglucose (18F-FDG) prior to surgery.

During surgery and not less than 120 minutes after injection of FDG, the primary lesion will be imaged using the EnLightTM system to determine margin status.

Gastrointestinal tumour excision surgery will then be performed according to standard of care. The surgical cavity and the lymph nodes will be imaged by the EnLightTM system to establish whether other radioactive tissue remain. These results will not influence any surgical or clinical decision-making, which will remain as standard of care. The resected tumour excision specimen will be imaged by the LightPathTM Imaging System. The resected tumour excision specimen will, in addition, be analysed according to standard of care pathology. The surgeon and surgical staff will be monitored for external exposure to ionizing radiation by means of dosimeters, and position sensors during surgery.

Patients will be followed-up (Visit 3) within a 2 - 14 day window after the end of surgery for adverse events (AEs). Those related to the use of the investigational devices, or the PET imaging agent will be identified as such.

Undersøgelsestype

Observationel

Kontakter og lokationer

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

Studiesteder

  • Ungarn
      • Budapest, Ungarn
        • Semmelweis University First Clinic of Surgery

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

30 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Female or male patients aged ≥ 30 years diagnosed with gastric, pancreatic, bile duct or duodenal cancer, whose treatment is to be tumour excision surgery.

Beskrivelse

Inclusion Criteria:

  1. Provides written informed consent to participate in the study.
  2. Is a man or woman aged ≥ 30 years.
  3. Patients diagnosed with gastric, pancreatic, bile duct or duodenal cancer whose treatment is to be tumour excision surgery.
  4. Life expectancy of at least 12 months.
  5. Blood glucose level < 12 mmol/l.

Exclusion Criteria:

  1. Participation in another clinical study either concurrently or within 180 days prior to surgery.
  2. Major surgery within 30 days before the baseline visit.
  3. Women who are pregnant or lactating.
  4. Renal impairment, hepatic impairment, serious infection or other life-threatening illness, other than cancer, within 60 days before surgery.
  5. Previous exposure to ionizing radiation >5 millisieverts (mSv) in the previous 12 months.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Andet
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
EnLightTM and LightPathTM Imaging Systems arm

Patients will first be injected intravenously with 2-5 MBq/kg, up to a maximum 300 MBq of the marketed product 18F-fluorodeoxyglucose (FDG) and after this undergo tumour excision surgery according to standard of care.

The surgical cavity will be imaged by the EnLightTM system and the tumour excision specimen will be imaged by both the EnLightTM and LightPathTM Imaging Systems. The EnLightTM and LightPathTM Imaging Systems results will not influence any surgical or clinical decision-making. The tumour excision specimen will be analysed according to standard of care pathology. Patients will be followed-up (Visit 3) 2-14 days after the end of surgery for adverse events (AEs).
Medicin: The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucose
The FDG is injected at least 120 minutes prior to the imaging by the EnLightTM and LightPathTM Imaging Systems
Andre navne:
  • FDG
Enhed: EnLightTM
The surgical cavity and the resected lymph nodes (if any) will be imaged by the EnLightTM system to establish whether radioactive tissue remains after surgery.
Enhed: LightPathTM Imaging System
The resected tumour excision specimens and the resected lymph nodes (if any)will be imaged by CLI and by WLI to establish whether they contain radioactive tissue.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The location of PET imaging agent as measured by beta particle detection
Tidsramme: Intraoperatively (during the single session of surgery on Day 0)
The EnLightTM will be used for determining the number of lesions, their location and margin status, in the surgical cavity including within surrounding tissue, and lymph nodes. The EnLightTM is a beta particle detector used for imaging the location of the PET imaging agent. It works both in a hot-spot mode, to localise areas with high beta particle detection signal from the PET imaging agent, and in an imaging mode that allows video imaging of areas where the PET imaging agent has accumulated.
Intraoperatively (during the single session of surgery on Day 0)
The location of PET imaging agent as measured by the LightPathTM Imaging System
Tidsramme: Intraoperatively (during the single session of surgery on Day 0)
The LightPathTM Imaging System will be used for determining the margin status of lesions and the metastatic involvement of lymph nodes.
Intraoperatively (during the single session of surgery on Day 0)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The number of lesions by histopathology
Tidsramme: Expected on average Day 10 after surgery
Number of lesions according to standard of care histopathology.
Expected on average Day 10 after surgery
The number of metastatic lymph nodes by histopathology
Tidsramme: Expected on average Day 10 after surgery
The number of metastatic lymph nodes according to standard of care histopathology.
Expected on average Day 10 after surgery
The extent of resection margins by histopathology
Tidsramme: Expected on average Day 10 after surgery
Extent of resection margins according to standard of care histopathology.
Expected on average Day 10 after surgery
Ease of use measured by questionnaire
Tidsramme: At the end of imaging on Day 0
Ease of use measured by study-specific questionnaire
At the end of imaging on Day 0
Radiation exposure
Tidsramme: At the time of discharge to the ward after surgery on Day 0
Radiological dose in microsieverts as measured by dosimeters worn by operating room staff
At the time of discharge to the ward after surgery on Day 0
Number of participants with adverse events
Tidsramme: Visit 3, at day 3-15
Patients will be followed-up until Visit 3, 2-14 days after the end of surgery on Day 0 for adverse events
Visit 3, at day 3-15

Samarbejdspartnere og efterforskere

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

Sponsor

Lightpoint Medical Limited

Samarbejdspartnere

Semmelweis University

Efterforskere

  • Studieleder: Sheryl O'Farrell, PhD, Head of Clinical Development

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

7. december 2022

Primær færdiggørelse (Faktiske)

1. januar 2016

Studieafslutning

7. december 2022

Datoer for studieregistrering

Først indsendt

27. april 2015

Først indsendt, der opfyldte QC-kriterier

13. maj 2015

Først opslået (Skøn)

18. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LPM-005

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 Mavekræft

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Peru

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner