Pancreas AdenocarcinomaPhase 2FLUOPANCNCT05518071
FLUOPANC-trial - Fluorescence-guided Surgery of Pancreatic and Bileduct Tumors Using cRGD-ZW800-1
A Phase 2 study testing CRGD-ZW800-1 and Intraoperative near-infrared fluorescence imaging in people with Pancreas Adenocarcinoma and Cholangiocarcinoma, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Pancreas as well as Cholangiocarcinoma have a dismal prognosis at time of diagnosis, due to late onset of clinical symptoms, patients present with advance disease. Complete surgical resection is the only potential curative treatment, however only a small percentage is eligible for upfront total surgical resection due… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Adenocarcinoma, Cholangiocarcinoma
- What is being tested?
- CRGD-ZW800-1 and Intraoperative near-infrared fluorescence imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Nov 2022to 23 May 2024
- Phase
- Phase 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
- Patients > 18 years old;
- Patients scheduled and eligible for open/robotic resection because of (histologically proven) pancreatic carcinoma with or without neoadjuvant treatment. As well as patients scheduled and eligible for resection because of (histologically proven) distal or perihilar cholangiocarcinoma with or without neoadjuvant treatment.
- All women of childbearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
- Patients should be capable and willing to give informed consent before study specific procedures;
Who cannot join
- History of a clinically significant allergy or anaphylactic reactions;
- Patients with renal insufficiency (eGFR<60 ml/min/1,73 m2);
- Patients with a previous kidney transplantation in the medical history;
- Pregnant women, or women giving breast feeding;
- Patients who are immunocompromised and do not have the ability to respond normally to an infection due to an impaired or weakened immune system, caused by either a pre-existing disease or concomitant medications (excluding intended neoadjuvant treatment);
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
- Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Near-infrared Fluorescence Imaging in Pancreatic- and Extrahepatic Bile Duct Tumors Using cRGD-ZW800-1 and Dedicated Imaging Systems: A Phase II Feasibility Testing, Dose-ranging and Optimal Dose-(Interval) Selection Trial
Pancreas as well as Cholangiocarcinoma have a dismal prognosis at time of diagnosis, due to late onset of clinical symptoms, patients present with advance disease. Complete surgical resection is the only potential curative treatment, however only a small percentage is eligible for upfront total surgical resection due to extension into anatomical related important vascular structures. Neoadjuvant chemo(radio)therapy has become the standard treatment modality for non-primary resectable disease (borderline resectable and locally advanced pancreatic cancer (LAPC)), where subsequent downstaging can make identification of the primary tumor more challenging during surgery. Near-infrared (NIR) fluorescence imaging can aid surgeons by providing real-time visualization of tumors, suspect lymph nodes and vital structures during surgery. Additional intra-operative feedback could possibly reduce the frequency of positive resection margins and increase complete removal of locally spread tumor and involved lymph nodes and could thereby improve patient outcomes as well as overall survival. cRGD-ZW800-1 is a targeted NIR-fluorophore, with specific binding capacity for integrins (αvβ3, αvβ5, αvβ6) which are overexpressed on tumor cells and tumor-associated vascular endothelium associated with neoangiogenesis.
Read the detailed description
Pancreatic cancer is one of the most common causes of death in the United States. With a median survival of less than 6 months, the prognosis is very poor. After diagnosis, the 1 and 5-year survival rates are around 25% and 10%, respectively. Surgical resection is the only curative treatment, but also results in relatively low survival and present recurrence risk, depending on the stage. In the same order of magnitude, bile duct cancer is also found, it can be classified according to location within or outside the liver, extrahepatic bile duct tumors are much anatomically related to pancreatic tumors, surgical treatment is therefore often the same: (partial) pancreatic resection. During surgery, it is difficult to distinguish between malignant and benign tissue, especially if patients have been treated neoadjuvantly. Currently, near-infrared fluorescence imaging is a technique with great potential to illuminate important structures during surgery. Fluorescent substances can be injected intravenously, which then specifically attach to malignant cells or tumor-associated structures, such as stroma or blood vessels, and emit light in the near-infrared spectrum (700-900 nm). Thus, with specially equipped camera systems, tumors literally light up and the surgeon can completely remove the tumors during surgery in real time. cRGD-ZW800-1 is a newly developed fluorescent agent, which binds to integrins, which are associated with neoangiogenesis, and has the potential to make tumor cells in the pancreas more visible during surgery in order to achieve more complete surgical (R0) resections.
Aims of the study:
- To assess the feasibility, safety and tolerability of cRGD-ZW800-1 for the visualization of pancreatic carcinomas, perihilar or distal cholangiocarcinomas and if present associated metastatic lymph nodes and their distant metastases in real-time using specific NIR fluorescence imaging systems.
- Determining the optimal dose and dose interval of a single intravenous bolus injection of cRGD-ZW800-1 for intraoperative NIR imaging
Study design:
Open label, dose-ranging and optimal dose-(interval) selection study, with a two-factorial design. In total 20 patients diagnosed with a malignant tumor of the pancreas, or distal/hilar bile ducts, which are eligible for surgical resection with or without neoadjuvant treatment will be enrolled. These patients will be distributed over four dosing-, and one expansion cohort: Cohort 1 (0.05mg/kg, 2-4h before intervention), Cohort 2 (0.05mg/kg, 14-24h before intervention), Cohort 3 (0.025mg/kg, 2-4h before intervention), Cohort 4 (0.025mg/kg, 14-24h before intervention) and Cohort 5 (expansion cohort). Patients are included if they met the inclusion/exclusion criteria and will be screened during pre-operative work-up for surgery.
Study population: Patients with or without neoadjuvant treatment eligible for surgical resection at the Leiden University Medical Center (LUMC) of histologically proven malignant tumors of the pancreas head, neck and tail. As well as patients with histologically proven tumors of the peri-hilar and distal bile ducts (extrahepatic cholangiocarcinomas) with or without neoadjuvant treatment.
Intervention: Single bolus injection of cRGD-ZW800-1 2-24h before surgery. Intra-operative in-vivo assessment of NIR-fluorescence of tumor, lymph nodes, possible distant metastasis and anatomical related structures. After resection ex-vivo assessment of NIR-fluorescence of all resected tissue, on gross-macroscopy, bread loafs and microscopic slides.
Investigational drug: Intravenous single bolus injection of the targeted NIR fluorophore cRGD-ZW800-1. This targeted 800nm zwitterionic fluorophore developed by the Hospital Pharmacy Department of LUMC consists of the fluorophore ZW800-1 conjugated to the cRGD peptide.
Imaging: Intraoperative imaging will be performed with at least one of the following CE-marked near-infrared (NIR) fluorescence imaging systems: Quest Spectrum imaging platform (v2/3.0) for open-procedures, the Olympus or Karl-Storz system for the diagnostic laparoscopy or the Intuitive Surgical Da Vinci Xi (Firefly-mode) for minimally invasive robot-assisted procedures. With a NIR-imaging system a potential fluorescent signal of the tumor can be evaluated. Furthermore, the Quest Spectrum platform will also be used for evaluation of ex-vivo fluorescence of resected tissue on the back table (Back table imaging) and pathology department (ex-vivo imaging), which shall be performed during and after every procedure.
- Conditions
- Pancreas Adenocarcinoma, Cholangiocarcinoma
- Being tested
- CRGD-ZW800-1, Intraoperative near-infrared fluorescence imaging
- Keywords
- Fluorescence Guided Surgery, Pancreatic Ductal Adenocarcinoma, Extrahepatic cholangiocarcinoma, Near-Infrared (NIR) Fluorescence imaging, Novel fluorescent probe, cRGD-ZW800-1
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRGD-ZW800-1Drug
Intravenous single bolus injection of the targeted NIR fluorophore cRGD-ZW800-1. This targeted 800nm zwitterionic fluorophore developed by the Hospital Pharmacy Department of LUMC consists of the fluorophore ZW800-1 conjugated to the cRGD peptide
Intraoperative near-infrared fluorescence imagingDevice
Intraoperative imaging will be performed with at least one of the following CE-marked near-infrared (NIR) fluorescence imaging systems: Quest Spectrum imaging platform (v2/3.0) for open-procedures, the Olympus or Karl-Storz system for the diagnostic laparoscopy or the Intuitive Surgical Da Vinci Xi (Firefly-mode) for minimally invasive robot-assisted procedures. With a NIR-imaging system a potential fluorescent signal of the tumor can be evaluated. Furthermore, the Quest Spectrum platform will also be used for evaluation of ex-vivo fluorescence of resected tissue on the back table (Back table imaging) and pathology department (ex-vivo imaging), which shall be performed during and after every procedure.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - N=4 (0.05mg/kg, 2-4h before intervention) | Experimental | Not described Receives: Drug: CRGD-ZW800-1; Device: Intraoperative near-infrared fluorescence imaging |
| Cohort 2 - N=4 (0.05mg/kg, 14-24h before intervention) | Experimental | Not described Receives: Drug: CRGD-ZW800-1; Device: Intraoperative near-infrared fluorescence imaging |
| Cohort 3 - N=4 (0.025mg/kg, 2-4h before intervention) | Experimental | Not described Receives: Drug: CRGD-ZW800-1; Device: Intraoperative near-infrared fluorescence imaging |
| Cohort 4 - N=4 (0.025mg/kg, 14-24h before intervention) | Experimental | Not described Receives: Drug: CRGD-ZW800-1; Device: Intraoperative near-infrared fluorescence imaging |
| Expansion cohort - N=4 (optimal dose, optimal dose-interval) | Experimental | Not described Receives: Drug: CRGD-ZW800-1; Device: Intraoperative near-infrared fluorescence imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of the primary tumor using cRGD-ZW800-1 and dedicated NIR-Fluorescence imaging system.
Visualization is measured using the tumor-to-background ratio (TBR) in in-vivo and ex-vivo setting. A tumor-to-background ratio (TBR) of at least ≥1.5 provides sufficient contrast for adequate visualization/delineation and will therefore be used as cut-off value.
Measured: Surgery
Secondary outcomes (5)
Number and grade of treatment-emergent (serious) adverse events ((S)AEs).
Measured: Enrollment - EOS
Concordance between clinical assessment, histopathologic examination and NIR-Fluorescence imaging assessment of the resected tumor, lymph nodes and/or metastatic lesions and their histopathologic result.
Measured: Surgery
Define the optimal dose and dose interval of a single intravenous bolus injection of cRGD-ZW800-1.
The optimal dose and ideal time window between administration of the study drug and intra-operative imaging during surgery will be assessed after all consecutive patients have been included, the endpoint for the combination of optimal dose and dose-interval is a tumor-to-background ratio of at least ≥1.5.
Measured: Enrollment - EOS
Tumor positive margins detected with NIR fluorescence imaging using cRGD-ZW800-1, referenced to histopathology.
Measured: Surgery
Number of tumor-positive lymph nodes and metastases detected by NIR fluorescence imaging using cRGD-ZW800-1, referenced to histopathology.
Measured: Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start9 Nov 2022
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreas AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Vahrmeijer, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518071
- Sponsor's protocol ID
- P21.128
- Other IDs
- 2019-004217-14, NL 71219.058.22, 2019
- Acronym
- FLUOPANC
- Status last verified
- Jun 2024
- First submitted
- 24 Aug 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
de Valk KS, Deken MM, Handgraaf HJM, Bhairosingh SS, Bijlstra OD, van Esdonk MJ, Terwisscha van Scheltinga AGT, Valentijn ARPM, March TL, Vuijk J, Peeters KCMJ, Holman FA, Hilling DE, Mieog JSD, Frangioni JV, Burggraaf J, Vahrmeijer AL. First-in-Human Assessment of cRGD-ZW800-1, a Zwitterionic, Integrin-Targeted, Near-Infrared Fluorescent Peptide in Colon Carcinoma. Clin Cancer Res. 2020 Aug 1;26(15):3990-3998. doi: 10.1158/1078-0432.CCR-19-4156. Epub 2020 Apr 28.
PubMed 32345649Handgraaf HJM, Boonstra MC, Prevoo HAJM, Kuil J, Bordo MW, Boogerd LSF, Sibinga Mulder BG, Sier CFM, Vinkenburg-van Slooten ML, Valentijn ARPM, Burggraaf J, van de Velde CJH, Frangioni JV, Vahrmeijer AL. Real-time near-infrared fluorescence imaging using cRGD-ZW800-1 for intraoperative visualization of multiple cancer types. Oncotarget. 2017 Mar 28;8(13):21054-21066. doi: 10.18632/oncotarget.15486.
PubMed 28416744
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Near-infrared Fluorescence Imaging in Pancreatic- and Extrahepatic Bile Duct Tumors Using cRGD-ZW800-1 and Dedicated Imaging Systems: A Phase II Feasibility Testing, Dose-ranging and Optimal Dose-(Interval) Selection Trial
- ClinicalTrials.gov ID
- NCT05518071
- Acronym / sponsor ID
- FLUOPANC / P21.128
- Conditions
- Pancreas Adenocarcinoma, Cholangiocarcinoma
- Keywords
- Fluorescence Guided Surgery, Pancreatic Ductal Adenocarcinoma, Extrahepatic cholangiocarcinoma, Near-Infrared (NIR) Fluorescence imaging, Novel fluorescent probe, cRGD-ZW800-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 26 Aug 2022 (actual)
- 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.
Pancreas as well as Cholangiocarcinoma have a dismal prognosis at time of diagnosis, due to late onset of clinical symptoms, patients present with advance disease. Complete surgical resection is the only potential curative treatment, however only a small percentage is eligible for upfront total surgical resection due to extension into anatomical related important vascular structures. Neoadjuvant chemo(radio)therapy has become the standard treatment modality for non-primary resectable disease (borderline resectable and locally advanced pancreatic cancer (LAPC)), where subsequent downstaging can make identification of the primary tumor more challenging during surgery. Near-infrared (NIR) fluorescence imaging can aid surgeons by providing real-time visualization of tumors, suspect lymph nodes and vital structures during surgery. Additional intra-operative feedback could possibly reduce the frequency of positive resection margins and increase complete removal of locally spread tumor and involved lymph nodes and could thereby improve patient outcomes as well as overall survival. cRGD-ZW800-1 is a targeted NIR-fluorophore, with specific binding capacity for integrins (αvβ3, αvβ5, αvβ6) which are overexpressed on tumor cells and tumor-associated vascular endothelium associated with neoangiogenesis.
Detailed description
Pancreatic cancer is one of the most common causes of death in the United States. With a median survival of less than 6 months, the prognosis is very poor. After diagnosis, the 1 and 5-year survival rates are around 25% and 10%, respectively. Surgical resection is the only curative treatment, but also results in relatively low survival and present recurrence risk, depending on the stage. In the same order of magnitude, bile duct cancer is also found, it can be classified according to location within or outside the liver, extrahepatic bile duct tumors are much anatomically related to pancreatic tumors, surgical treatment is therefore often the same: (partial) pancreatic resection. During surgery, it is difficult to distinguish between malignant and benign tissue, especially if patients have been treated neoadjuvantly. Currently, near-infrared fluorescence imaging is a technique with great potential to illuminate important structures during surgery. Fluorescent substances can be injected intravenously, which then specifically attach to malignant cells or tumor-associated structures, such as stroma or blood vessels, and emit light in the near-infrared spectrum (700-900 nm). Thus, with specially equipped camera systems, tumors literally light up and the surgeon can completely remove the tumors during surgery in real time. cRGD-ZW800-1 is a newly developed fluorescent agent, which binds to integrins, which are associated with neoangiogenesis, and has the potential to make tumor cells in the pancreas more visible during surgery in order to achieve more complete surgical (R0) resections.
Aims of the study:
- To assess the feasibility, safety and tolerability of cRGD-ZW800-1 for the visualization of pancreatic carcinomas, perihilar or distal cholangiocarcinomas and if present associated metastatic lymph nodes and their distant metastases in real-time using specific NIR fluorescence imaging systems.
- Determining the optimal dose and dose interval of a single intravenous bolus injection of cRGD-ZW800-1 for intraoperative NIR imaging
Study design:
Open label, dose-ranging and optimal dose-(interval) selection study, with a two-factorial design. In total 20 patients diagnosed with a malignant tumor of the pancreas, or distal/hilar bile ducts, which are eligible for surgical resection with or without neoadjuvant treatment will be enrolled. These patients will be distributed over four dosing-, and one expansion cohort: Cohort 1 (0.05mg/kg, 2-4h before intervention), Cohort 2 (0.05mg/kg, 14-24h before intervention), Cohort 3 (0.025mg/kg, 2-4h before intervention), Cohort 4 (0.025mg/kg, 14-24h before intervention) and Cohort 5 (expansion cohort). Patients are included if they met the inclusion/exclusion criteria and will be screened during pre-operative work-up for surgery.
Study population: Patients with or without neoadjuvant treatment eligible for surgical resection at the Leiden University Medical Center (LUMC) of histologically proven malignant tumors of the pancreas head, neck and tail. As well as patients with histologically proven tumors of the peri-hilar and distal bile ducts (extrahepatic cholangiocarcinomas) with or without neoadjuvant treatment.
Intervention: Single bolus injection of cRGD-ZW800-1 2-24h before surgery. Intra-operative in-vivo assessment of NIR-fluorescence of tumor, lymph nodes, possible distant metastasis and anatomical related structures. After resection ex-vivo assessment of NIR-fluorescence of all resected tissue, on gross-macroscopy, bread loafs and microscopic slides.
Investigational drug: Intravenous single bolus injection of the targeted NIR fluorophore cRGD-ZW800-1. This targeted 800nm zwitterionic fluorophore developed by the Hospital Pharmacy Department of LUMC consists of the fluorophore ZW800-1 conjugated to the cRGD peptide.
Imaging: Intraoperative imaging will be performed with at least one of the following CE-marked near-infrared (NIR) fluorescence imaging systems: Quest Spectrum imaging platform (v2/3.0) for open-procedures, the Olympus or Karl-Storz system for the diagnostic laparoscopy or the Intuitive Surgical Da Vinci Xi (Firefly-mode) for minimally invasive robot-assisted procedures. With a NIR-imaging system a potential fluorescent signal of the tumor can be evaluated. Furthermore, the Quest Spectrum platform will also be used for evaluation of ex-vivo fluorescence of resected tissue on the back table (Back table imaging) and pathology department (ex-vivo imaging), which shall be performed during and after every procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - N=4 (0.05mg/kg, 2-4h before intervention) | Experimental | Drug: CRGD-ZW800-1, Device: Intraoperative near-infrared fluorescence imaging |
| Cohort 2 - N=4 (0.05mg/kg, 14-24h before intervention) | Experimental | Drug: CRGD-ZW800-1, Device: Intraoperative near-infrared fluorescence imaging |
| Cohort 3 - N=4 (0.025mg/kg, 2-4h before intervention) | Experimental | Drug: CRGD-ZW800-1, Device: Intraoperative near-infrared fluorescence imaging |
| Cohort 4 - N=4 (0.025mg/kg, 14-24h before intervention) | Experimental | Drug: CRGD-ZW800-1, Device: Intraoperative near-infrared fluorescence imaging |
| Expansion cohort - N=4 (optimal dose, optimal dose-interval) | Experimental | Drug: CRGD-ZW800-1, Device: Intraoperative near-infrared fluorescence imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients > 18 years old;
- Patients scheduled and eligible for open/robotic resection because of (histologically proven) pancreatic carcinoma with or without neoadjuvant treatment. As well as patients scheduled and eligible for resection because of (histologically proven) distal or perihilar cholangiocarcinoma with or without neoadjuvant treatment.
- All women of childbearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
- Patients should be capable and willing to give informed consent before study specific procedures;
Key exclusion criteria (7 listed)
- History of a clinically significant allergy or anaphylactic reactions;
- Patients with renal insufficiency (eGFR<60 ml/min/1,73 m2);
- Patients with a previous kidney transplantation in the medical history;
- Pregnant women, or women giving breast feeding;
- Patients who are immunocompromised and do not have the ability to respond normally to an infection due to an impaired or weakened immune system, caused by either a pre-existing disease or concomitant medications (excluding intended neoadjuvant treatment);
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 |
|---|---|---|
| CRGD-ZW800-1Intravenous single bolus injection of the targeted NIR fluorophore cRGD-ZW800-1. This targeted 800nm zwitterionic fluorophore developed by the Hospital Pharmacy Department of LUMC consists of the fluorophore ZW800-1 conjugated to the cRGD peptide | Drug | Cohort 1 - N=4 (0.05mg/kg, 2-4h before intervention), Cohort 2 - N=4 (0.05mg/kg, 14-24h before intervention), Cohort 3 - N=4 (0.025mg/kg, 2-4h before intervention), Cohort 4 - N=4 (0.025mg/kg, 14-24h before intervention), Expansion cohort - N=4 (optimal dose, optimal dose-interval) |
| Intraoperative near-infrared fluorescence imagingIntraoperative imaging will be performed with at least one of the following CE-marked near-infrared (NIR) fluorescence imaging systems: Quest Spectrum imaging platform (v2/3.0) for open-procedures, the Olympus or Karl-Storz system for the diagnostic laparoscopy or the Intuitive Surgical Da Vinci Xi (Firefly-mode) for minimally invasive robot-assisted procedures. With a NIR-imaging system a potential fluorescent signal of the tumor can be evaluated. Furthermore, the Quest Spectrum platform will also be used for evaluation of ex-vivo fluorescence of resected tissue on the back table (Back table imaging) and pathology department (ex-vivo imaging), which shall be performed during and after every procedure. | Device | Cohort 1 - N=4 (0.05mg/kg, 2-4h before intervention), Cohort 2 - N=4 (0.05mg/kg, 14-24h before intervention), Cohort 3 - N=4 (0.025mg/kg, 2-4h before intervention), Cohort 4 - N=4 (0.025mg/kg, 14-24h before intervention), Expansion cohort - N=4 (optimal dose, optimal dose-interval) |
Primary outcome
Visualization of the primary tumor using cRGD-ZW800-1 and dedicated NIR-Fluorescence imaging system.
Time frame: Surgery
Visualization is measured using the tumor-to-background ratio (TBR) in in-vivo and ex-vivo setting. A tumor-to-background ratio (TBR) of at least ≥1.5 provides sufficient contrast for adequate visualization/delineation and will therefore be used as cut-off value.
5 secondary outcomes
Number and grade of treatment-emergent (serious) adverse events ((S)AEs).
Time frame: Enrollment - EOS
Concordance between clinical assessment, histopathologic examination and NIR-Fluorescence imaging assessment of the resected tumor, lymph nodes and/or metastatic lesions and their histopathologic result.
Time frame: Surgery
Define the optimal dose and dose interval of a single intravenous bolus injection of cRGD-ZW800-1.
Time frame: Enrollment - EOS
Tumor positive margins detected with NIR fluorescence imaging using cRGD-ZW800-1, referenced to histopathology.
Time frame: Surgery
Number of tumor-positive lymph nodes and metastases detected by NIR fluorescence imaging using cRGD-ZW800-1, referenced to histopathology.
Time frame: Surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Background: PubMed 32345649de Valk KS, Deken MM, Handgraaf HJM, Bhairosingh SS, Bijlstra OD, van Esdonk MJ, Terwisscha van Scheltinga AGT, Valentijn ARPM, March TL, Vuijk J, Peeters KCMJ, Holman FA, Hilling DE, Mieog JSD, Frangioni JV, Burggraaf J, Vahrmeijer AL. First-in-Human Assessment of cRGD-ZW800-1, a Zwitterionic, Integrin-Targeted, Near-Infrared Fluorescent Peptide in Colon Carcinoma. Clin Cancer Res. 2020 Aug 1;26(15):3990-3998. doi: 10.1158/1078-0432.CCR-19-4156. Epub 2020 Apr 28.
- Background: PubMed 28416744Handgraaf HJM, Boonstra MC, Prevoo HAJM, Kuil J, Bordo MW, Boogerd LSF, Sibinga Mulder BG, Sier CFM, Vinkenburg-van Slooten ML, Valentijn ARPM, Burggraaf J, van de Velde CJH, Frangioni JV, Vahrmeijer AL. Real-time near-infrared fluorescence imaging using cRGD-ZW800-1 for intraoperative visualization of multiple cancer types. Oncotarget. 2017 Mar 28;8(13):21054-21066. doi: 10.18632/oncotarget.15486.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CRGD-ZW800-1 and Intraoperative near-infrared fluorescence imaging in people with Pancreas Adenocarcinoma and Cholangiocarcinoma, run by Leiden University Medical Center at 1 site 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 7 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: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visualization of the primary tumor using cRGD-ZW800-1 and dedicated NIR-Fluorescence imaging system. (time frame: Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05518071, which also lists 2 linked publications.
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 24 Jun 2024.