Pancreatic Cancer Clinical Trial
— CLIOOfficial title:
Evaluation of the Use of Intra-operative Molecular Imaging With BetaScope and in Vitro Measurement With LightPath Specimen Analyser Devices in Gastrointestinal Tumour Surgery
NCT number | NCT02446379 |
Other study ID # | LPM-005 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | April 27, 2015 |
Last updated | January 25, 2017 |
Verified date | January 2017 |
Source | Lightpoint Medical Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | January 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Hungary | Semmelweis University First Clinic of Surgery | Budapest |
Lead Sponsor | Collaborator |
---|---|
Lightpoint Medical Limited | Semmelweis University |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The location of PET imaging agent as measured by beta particle detection | 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) | |
Primary | The location of PET imaging agent as measured by the LightPathTM Imaging System | 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) | |
Secondary | The number of lesions by histopathology | Number of lesions according to standard of care histopathology. | Expected on average Day 10 after surgery | |
Secondary | The number of metastatic lymph nodes by histopathology | The number of metastatic lymph nodes according to standard of care histopathology. | Expected on average Day 10 after surgery | |
Secondary | The extent of resection margins by histopathology | Extent of resection margins according to standard of care histopathology. | Expected on average Day 10 after surgery | |
Secondary | Ease of use measured by questionnaire | Ease of use measured by study-specific questionnaire | At the end of imaging on Day 0 | |
Secondary | Radiation exposure | 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 | |
Secondary | Number of participants with adverse events | 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 |
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