Pancreatic CancerPhase 1/2PANCOSILNCT07595835
CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer
A Phase 1/2 study testing CT-guided percutaneous intratumoural implantation of the OncoSil™ device in people with Pancreatic Cancer, run by M.R. Meijerink at 1 site in Netherlands.
Trial summary
Pancreatic ductal adenocarcinoma is a highly lethal cancer, and approximately 40% of patients present with non-metastatic locally advanced pancreatic cancer (LAPC) that is not suitable for surgical resection. To improve outcomes in this patient group, local ablative treatments are being explored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- CT-guided percutaneous intratumoural implantation of the OncoSil™ device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Jun 2023to 1 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Locally advanced pancreatic cancer, defined by the DPCG consensus criteria as: arterial involvement >90 degrees or venous involvement >270 degrees.
- At least RECIST stable disease after a minimum two months of chemotherapy according to current clinical practice*
- Capable of providing written and oral informed consent
- Candidate for RNT, judged by a multidisciplinary tumor board
- WHO 0-2
Who cannot join
- Eligibility for resection
- Participation in other trials focussing on different ablative treatment modalities such as radiofrequency ablation or irreversible electroporation for LAPC
- Known hypersensitivity to silicon or phosphor
- Bleeding disorders which cannot be corrected with medication
- Inability/unwillingness to interrupt anticoagulation therapy
- Pregnancy
Show all 13Show fewer
- Metastatic pancreatic cancer
- Epilepsy episode(s) in the past six months
- Longest tumor diameter >70 mm or total target tumor volume >110 ml
- Presence of multiple collateral vessels surrounding or adjacent to the target tumor on radiologic imagining, prohibiting safe injection of the OncosilTM device
- Presence (or significant risk) of varices near the target tumor on radiologic imaging
- Recent clinically significant pancreatitis
- Previous administration of radiotherapy to the pancreas
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC - Location VUmc
Amsterdam, North Holland, 1081 HV
Danielle J.W. Vos, +3120-4444571, interventieradiologie@amsterdamumc.nl
About this study
Official title: Safety and Feasibility of CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer (PANCOSIL): an Open-label, Single-arm Phase 1-2 Feasibility Study
Pancreatic ductal adenocarcinoma is a highly lethal cancer, and approximately 40% of patients present with non-metastatic locally advanced pancreatic cancer (LAPC) that is not suitable for surgical resection. To improve outcomes in this patient group, local ablative treatments are being explored. Radionuclide therapy (RNT) is a promising option that delivers high-dose internal radiation directly into the tumor, potentially achieving better local tumor control while sparing surrounding tissues compared with external-beam radiation therapy. The OncoSil™ device is a type of RNT containing Phosphorus-32-radiolabeled microparticles. The ³²P microparticles have been designed to deliver a localized distribution of beta-radiation within the target tumor up to 100 Gy, which causes direct damage to cancer cell DNA and renders them incapable of further cell division and proliferation. Favorable results have been reported by implanting ³²P microparticles intra-tumorally, which is typically administered via endoscopic ultrasound guidance. A percutaneous approach may allow for more precise and reproducible delivery, but prospective data on its safety and feasibility are lacking.
This prospective, single-arm phase 1-2 feasibility study aims to evaluate the safety and feasibility of percutaneous CT- guided RNT using ³²P microparticles in patients with non-progressive LAPC following induction chemotherapy. Twenty adult patients with pathology-confirmed LAPC, showing non-progressive disease according to RECIST, will be included after multidisciplinary tumor board review. Patients will undergo percutaneous, CT-guided implantation of ³²P microparticles under general anesthesia, sedation, or local analgesia depending on study phase and clinical judgment, followed by continuation of standard systemic chemotherapy and routine follow-up.
The primary endpoint is the rate of adverse events (CTCAE grade ≥3) occurring during the procedure and within 90 days afterward. Secondary endpoints include technical success, all adverse events, best overall respons, overall and progression-free survival, and changes in tumor markers.
- Conditions
- Pancreatic Cancer
- Being tested
- CT-guided percutaneous intratumoural implantation of the OncoSil™ device
- Keywords
- radionucleide therapy, brachytherapy, P32, internal radiotherapy, LAPC, ³²P microparticles, Oncosil
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided percutaneous intratumoural implantation of the OncoSil™ deviceDevice
CT-guided percutaneous intratumoural implantation of the OncoSil™ device, containing ³²P microparticles as a form of radionucleide therapy for 20 patients diagnosed with RECIST-stable LAPC after 2 months of systemic therapy.
| Study group | Role | What they receive |
|---|---|---|
| CT-guided percutaneous intratumoural implantation of ³²P microparticles for LAPC | Experimental | CT-guided percutaneous intratumoural implantation of the OncoSil™ device, containing ³²P microparticles as a form of radionucleide therapy for 20 patients diagnosed with RECIST-stable LAPC after 2 months of systemic therapy. Receives: Device: CT-guided percutaneous intratumoural implantation of the OncoSil™ device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety defined as the rate of procedure- or device-related CTCAE grade ≥3 adverse events (AEs) within 90 days after implantion.
Measured: From implantation to 90 days after implantation
Secondary outcomes (8)
Technical succes defined a the rate of adequate punctures and subsequent complete intratumoral delivery of the planned dose.
Measured: Periprocedural.
Overall safety defined as the rate of adverse events.
Measured: From implantation until 90 days after implantation.
Duration of implantation procedure defined as the total time of punction.
Measured: Periprocedural.
Duration of overall procedure defined as the total time in the radiology suite.
Measured: Periprocedural.
Overall survival
Measured: Defined from diagnosis and from implantion untill death by any cause, assessed up to end of study or up to 1 year after implantation.
Local, distant and overall progression free survival
Measured: Defined from diagnosis and from implantation until local and/or distant progression, or death, assessed up to end of study or up to 1 year after implantation.
Changes in serum CA19.9 during the first three months after implantation.
Measured: From implantation until three months after implantation.
Visual confirmation of intra-tumoral delivery of ³²P microparticles or other off-target deposition.
Measured: SPECT-imaging at +4 hours and +7 days after implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start4 Jun 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.R. Meijerink
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, M.R. Meijerink, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595835
- Sponsor's protocol ID
- NL78596.000.22
- Acronym
- PANCOSIL
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer (PANCOSIL): an Open-label, Single-arm Phase 1-2 Feasibility Study
- ClinicalTrials.gov ID
- NCT07595835
- Acronym / sponsor ID
- PANCOSIL / NL78596.000.22
- Conditions
- Pancreatic Cancer
- Keywords
- radionucleide therapy, brachytherapy, P32, internal radiotherapy, LAPC, ³²P microparticles, Oncosil
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.R. MeijerinkUniversity, hospital or other
- Study start
- 4 Jun 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 19 May 2026 (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.
Pancreatic ductal adenocarcinoma is a highly lethal cancer, and approximately 40% of patients present with non-metastatic locally advanced pancreatic cancer (LAPC) that is not suitable for surgical resection. To improve outcomes in this patient group, local ablative treatments are being explored. Radionuclide therapy (RNT) is a promising option that delivers high-dose internal radiation directly into the tumor, potentially achieving better local tumor control while sparing surrounding tissues compared with external-beam radiation therapy. The OncoSil™ device is a type of RNT containing Phosphorus-32-radiolabeled microparticles. The ³²P microparticles have been designed to deliver a localized distribution of beta-radiation within the target tumor up to 100 Gy, which causes direct damage to cancer cell DNA and renders them incapable of further cell division and proliferation. Favorable results have been reported by implanting ³²P microparticles intra-tumorally, which is typically administered via endoscopic ultrasound guidance. A percutaneous approach may allow for more precise and reproducible delivery, but prospective data on its safety and feasibility are lacking.
This prospective, single-arm phase 1-2 feasibility study aims to evaluate the safety and feasibility of percutaneous CT- guided RNT using ³²P microparticles in patients with non-progressive LAPC following induction chemotherapy. Twenty adult patients with pathology-confirmed LAPC, showing non-progressive disease according to RECIST, will be included after multidisciplinary tumor board review. Patients will undergo percutaneous, CT-guided implantation of ³²P microparticles under general anesthesia, sedation, or local analgesia depending on study phase and clinical judgment, followed by continuation of standard systemic chemotherapy and routine follow-up.
The primary endpoint is the rate of adverse events (CTCAE grade ≥3) occurring during the procedure and within 90 days afterward. Secondary endpoints include technical success, all adverse events, best overall respons, overall and progression-free survival, and changes in tumor markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT-guided percutaneous intratumoural implantation of ³²P microparticles for LAPC | Experimental | Device: CT-guided percutaneous intratumoural implantation of the OncoSil™ deviceCT-guided percutaneous intratumoural implantation of the OncoSil™ device, containing ³²P microparticles as a form of radionucleide therapy for 20 patients diagnosed with RECIST-stable LAPC after 2 months of systemic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Locally advanced pancreatic cancer, defined by the DPCG consensus criteria as: arterial involvement >90 degrees or venous involvement >270 degrees.
- At least RECIST stable disease after a minimum two months of chemotherapy according to current clinical practice*
- Capable of providing written and oral informed consent
- Candidate for RNT, judged by a multidisciplinary tumor board
Key exclusion criteria (13 listed)
- Eligibility for resection
- Participation in other trials focussing on different ablative treatment modalities such as radiofrequency ablation or irreversible electroporation for LAPC
- Known hypersensitivity to silicon or phosphor
- Bleeding disorders which cannot be corrected with medication
- Inability/unwillingness to interrupt anticoagulation therapy
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 |
|---|---|---|
| CT-guided percutaneous intratumoural implantation of the OncoSil™ deviceCT-guided percutaneous intratumoural implantation of the OncoSil™ device, containing ³²P microparticles as a form of radionucleide therapy for 20 patients diagnosed with RECIST-stable LAPC after 2 months of systemic therapy. | Device | CT-guided percutaneous intratumoural implantation of ³²P microparticles for LAPC |
Primary outcome
Safety defined as the rate of procedure- or device-related CTCAE grade ≥3 adverse events (AEs) within 90 days after implantion.
Time frame: From implantation to 90 days after implantation
8 secondary outcomes
Technical succes defined a the rate of adequate punctures and subsequent complete intratumoral delivery of the planned dose.
Time frame: Periprocedural.
Overall safety defined as the rate of adverse events.
Time frame: From implantation until 90 days after implantation.
Duration of implantation procedure defined as the total time of punction.
Time frame: Periprocedural.
Duration of overall procedure defined as the total time in the radiology suite.
Time frame: Periprocedural.
Overall survival
Time frame: Defined from diagnosis and from implantion untill death by any cause, assessed up to end of study or up to 1 year after implantation.
Local, distant and overall progression free survival
Time frame: Defined from diagnosis and from implantation until local and/or distant progression, or death, assessed up to end of study or up to 1 year after implantation.
Changes in serum CA19.9 during the first three months after implantation.
Time frame: From implantation until three months after implantation.
Visual confirmation of intra-tumoral delivery of ³²P microparticles or other off-target deposition.
Time frame: SPECT-imaging at +4 hours and +7 days after implantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- 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.
1 site 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 CT-guided percutaneous intratumoural implantation of the OncoSil™ device in people with Pancreatic Cancer, run by M.R. Meijerink 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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle J.W. Vos (+31204444571, d.vos@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety defined as the rate of procedure- or device-related CTCAE grade ≥3 adverse events (AEs) within 90 days after implantion. (time frame: From implantation to 90 days after implantation). 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 22 May 2026.