- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02446379
Use of the EnLightTM and LightPathTM Imaging Systems in Gastrointestinal Tumour Surgery (CLIO)
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Kontakter och platser
Studieorter
-
-
-
Budapest, Ungern
- Semmelweis University First Clinic of Surgery
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Provides written informed consent to participate in the study.
- Is a man or woman aged ≥ 30 years.
- Patients diagnosed with gastric, pancreatic, bile duct or duodenal cancer whose treatment is to be tumour excision surgery.
- Life expectancy of at least 12 months.
- Blood glucose level < 12 mmol/l.
Exclusion Criteria:
- Participation in another clinical study either concurrently or within 180 days prior to surgery.
- Major surgery within 30 days before the baseline visit.
- Women who are pregnant or lactating.
- Renal impairment, hepatic impairment, serious infection or other life-threatening illness, other than cancer, within 60 days before surgery.
- Previous exposure to ionizing radiation >5 millisieverts (mSv) in the previous 12 months.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Övrig
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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). |
The FDG is injected at least 120 minutes prior to the imaging by the EnLightTM and LightPathTM Imaging Systems
Andra namn:
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.
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The location of PET imaging agent as measured by beta particle detection
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The number of lesions by histopathology
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Sheryl O'Farrell, PhD, Head of Clinical Development
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Adenocarcinom
- Carcinom
- Neoplasmer, körtel och epitel
- Gastrointestinala sjukdomar
- Tarmsjukdomar
- Intestinala neoplasmer
- Duodenal sjukdomar
- Gallvägssjukdomar
- Gallgångssjukdomar
- Neoplasmer i gallvägarna
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Kolangiokarcinom
- Gallgångsneoplasmer
- Duodenala neoplasmer
- Molekylära mekanismer för farmakologisk verkan
- Radiofarmaka
- Fluorodeoxiglukos F18
Andra studie-ID-nummer
- LPM-005
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
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 .
Kliniska prövningar på Magcancer
-
Universitätsklinikum Hamburg-EppendorfCentre Hospitalier Universitaire de Nice; Olympus Corporation; Keio University och andra samarbetspartnersAvslutadGastric Focal LesionFrankrike
-
Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AvslutadRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertikal sleeve gastrectomy | Magbandning | Bypass, GastricFörenta staterna
-
RSP Systems A/SAvslutad
-
State University of New York - Upstate Medical...AvslutadGastric Bypass StatusFörenta staterna
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)IndragenGastric Bypass-kirurgi
-
Medtronic - MITGAvslutad
-
DuomedAktiv, inte rekryterandeFetma | Gastrektomi | Roux-en-Y Gastric Bypass | Mini Gastric BypassBelgien
-
Wageningen UniversityRijnstate HospitalOkändRoux-en-Y Gastric BypassNederländerna
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAvslutadRoux en Y Gastric BypassFörenta staterna
-
Olympus Corporation of the AmericasUnity Health TorontoAvslutad