Pancreatic CancerPhase 1/2PENGUINNCT02743975
Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma
A Phase 1/2 study testing Bevacizumab-800CW in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by University Medical Center Groningen at 3 sites in Netherlands.
Trial summary
There is a need for better visualization of resection margins and detection of small tumor deposits during surgery for pancreatic cancer. Optical molecular imaging of pancreatic ductal adenocarcinoma associated biomarkers is a promising technique to accommodate this need. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Adenocarcinoma
- What is being tested?
- Bevacizumab-800CW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Dec 2016to 1 May 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Patients with clinical suspicion of pancreatic head cancer who are scheduled to undergo surgical intervention with curative intent
- World Health Organization (WHO) performance score 0-2.
- Signed written informed consent
Who cannot join
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Other invasive malignancy
- Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre- menopausal women with intact reproductive organs and women less than two years after menopause.
- Prior neo-adjuvant chemo- of radiotherapy
- History of infusion reactions to bevacizumab or other monoclonal antibody therapies.
- Inadequately controlled hypertension with or without current antihypertensive medications
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- Within 6 months prior to inclusion: myocardial infarction, Transient Ischemic Attack, Cerebral Vascular Accident, pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris.
- Anticoagulant therapy with vitamine K antagonists
- Patients receiving Class 1A (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- Evidence of QTc (corrected QT interval) prolongation on pretreatment ECG (greater than 44ms in males of greater than 450ms in females)
- Magnesium, potassium and calcium below the lower limit of normal range.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
University Medical Center Groningen
Groningen, 9713 GZ
Leiden University Medical Center
Leiden
Radboud University Medical Center
Nijmegen
About this study
Official title: Intraoperative Detection of Cancer Tissue in Pancreatic Adenocarcinoma Using a VEGF-targeted Optical Fluorescent Imaging Tracer, A Multicentre Feasibility Dose Escalation Study
There is a need for better visualization of resection margins and detection of small tumor deposits during surgery for pancreatic cancer. Optical molecular imaging of pancreatic ductal adenocarcinoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in pancreatic cancer tissue versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling pancreatic cancer visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (4,5 10, 25 or 50mg) to detect pancreatic cancer tissue intraoperatively.
- Conditions
- Pancreatic Cancer, Pancreatic Adenocarcinoma
- Being tested
- Bevacizumab-800CW
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab-800CWDrug
Also called Bevacizumab-IRDye800CW
dose finding: 4.5mg; 10mg; 25mg; 50mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Bevacizumab-800CW Receives: Drug: Bevacizumab-800CW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracer accumulation in tumor tissue vs normal pancreatic tissue assessed by intraoperatively and ex vivo measuring of the mean fluorescent intensity
Mean Fluorescent Intensity (MFI) measured in tumor tissue compared to normal pancreatic tissue at macroscopic and microscopic level
Measured: up to 6 months
Finding optimal dose of Bevacizumab-800CW for intraoperative imaging of pancreatic cancer measured by calculating Target to Background ratios (TBR)
TBR of each dose group assessed by intraoperative imaging as well as ex vivo imaging
Measured: 3 days after tracer injection
Secondary outcomes (1)
Number of participants with treatment-related adverse events
Measured: Up to 4 weeks after tracer injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start1 Dec 2016
- Primary completion26 Feb 2018
- Study completion1 May 2018
Why it stopped: Insufficient tumor-to-background ratios in the first three dose groups
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- phase I/II safety and dose-finding study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Principal investigator, G.M. van Dam, University Medical Center Groningen
- Investigators
- Gooitzen van Dam, MD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743975
- Sponsor's protocol ID
- NL50488.042.15
- Acronym
- PENGUIN
- Status last verified
- Jan 2020
- First submitted
- 11 Apr 2016
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Detection of Cancer Tissue in Pancreatic Adenocarcinoma Using a VEGF-targeted Optical Fluorescent Imaging Tracer, A Multicentre Feasibility Dose Escalation Study
- ClinicalTrials.gov ID
- NCT02743975
- Acronym / sponsor ID
- PENGUIN / NL50488.042.15
- Conditions
- Pancreatic Cancer, Pancreatic Adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient tumor-to-background ratios in the first three dose groups
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 26 Feb 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a need for better visualization of resection margins and detection of small tumor deposits during surgery for pancreatic cancer. Optical molecular imaging of pancreatic ductal adenocarcinoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in pancreatic cancer tissue versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling pancreatic cancer visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (4,5 10, 25 or 50mg) to detect pancreatic cancer tissue intraoperatively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- phase I/II safety and dose-finding study
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Bevacizumab-800CWBevacizumab-800CW |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Patients with clinical suspicion of pancreatic head cancer who are scheduled to undergo surgical intervention with curative intent
- World Health Organization (WHO) performance score 0-2.
- Signed written informed consent
Key exclusion criteria (11 listed)
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Other invasive malignancy
- Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre- menopausal women with intact reproductive organs and women less than two years after menopause.
- Prior neo-adjuvant chemo- of radiotherapy
- History of infusion reactions to bevacizumab or other monoclonal antibody therapies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab-800CWAlso: Bevacizumab-IRDye800CWdose finding: 4.5mg; 10mg; 25mg; 50mg | Drug | Treatment group |
Primary outcome
Tracer accumulation in tumor tissue vs normal pancreatic tissue assessed by intraoperatively and ex vivo measuring of the mean fluorescent intensity
Time frame: up to 6 months
Mean Fluorescent Intensity (MFI) measured in tumor tissue compared to normal pancreatic tissue at macroscopic and microscopic level
Finding optimal dose of Bevacizumab-800CW for intraoperative imaging of pancreatic cancer measured by calculating Target to Background ratios (TBR)
Time frame: 3 days after tracer injection
TBR of each dose group assessed by intraoperative imaging as well as ex vivo imaging
1 secondary outcome
Number of participants with treatment-related adverse events
Time frame: Up to 4 weeks after tracer injection
Results and safety
The study was stopped early (reason given: Insufficient tumor-to-background ratios in the first three dose groups). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gooitzen van Dam, MD principal investigator
University Medical Center Groningen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bevacizumab-800CW in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by University Medical Center Groningen at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient tumor-to-background ratios in the first three dose groups). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracer accumulation in tumor tissue vs normal pancreatic tissue assessed by intraoperatively and ex vivo measuring of the mean fluorescent intensity (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.