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CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer (PANCOSIL)

19. mai 2026 oppdatert av: M.R. Meijerink

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CT-guided percutaneous intratumoural implantation of ³²P microparticles for LAPC
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.
Enhet: CT-guided percutaneous intratumoural implantation of the OncoSil™ device
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Safety defined as the rate of procedure- or device-related CTCAE grade ≥3 adverse events (AEs) within 90 days after implantion.
Tidsramme: From implantation to 90 days after implantation
From implantation to 90 days after implantation

Sekundære resultatmål

Resultatmål
Tidsramme
Technical succes defined a the rate of adequate punctures and subsequent complete intratumoral delivery of the planned dose.
Tidsramme: Periprocedural.
Periprocedural.
Overall safety defined as the rate of adverse events.
Tidsramme: From implantation until 90 days after implantation.
From implantation until 90 days after implantation.
Duration of implantation procedure defined as the total time of punction.
Tidsramme: Periprocedural.
Periprocedural.
Duration of overall procedure defined as the total time in the radiology suite.
Tidsramme: Periprocedural.
Periprocedural.
Overall survival
Tidsramme: Defined from diagnosis and from implantion untill death by any cause, assessed up to end of study or up to 1 year after implantation.
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
Tidsramme: 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.
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.
Tidsramme: From implantation until three months after implantation.
From implantation until three months after implantation.
Visual confirmation of intra-tumoral delivery of ³²P microparticles or other off-target deposition.
Tidsramme: SPECT-imaging at +4 hours and +7 days after implantation.
SPECT-imaging at +4 hours and +7 days after implantation.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

M.R. Meijerink

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. juni 2023

Primær fullføring (Antatt)

1. juni 2026

Studiet fullført (Antatt)

1. juni 2026

Datoer for studieregistrering

Først innsendt

26. januar 2026

Først innsendt som oppfylte QC-kriteriene

12. mai 2026

Først lagt ut (Faktiske)

19. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. mai 2026

Sist bekreftet

1. februar 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NL78596.000.22

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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