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

25 gennaio 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Ritirato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

30 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Altro
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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).
Droga: 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
Altri nomi:
  • F DG
Dispositivo: 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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The location of PET imaging agent as measured by beta particle detection
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The number of lesions by histopathology
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Lightpoint Medical Limited

Collaboratori

Semmelweis University

Investigatori

  • Direttore dello studio: Sheryl O'Farrell, PhD, Head of Clinical Development

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

7 dicembre 2022

Completamento primario (Effettivo)

1 gennaio 2016

Completamento dello studio

7 dicembre 2022

Date di iscrizione allo studio

Primo inviato

27 aprile 2015

Primo inviato che soddisfa i criteri di controllo qualità

13 maggio 2015

Primo Inserito (Stima)

18 maggio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 gennaio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 gennaio 2017

Ultimo verificato

1 gennaio 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LPM-005

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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