Alpha Radiation Emitters Device (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer

Conditions

• Metastatic Pancreatic Cancer
• Pancreatic Adenocarcinoma
• Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) — DEVICE
  DaRT source will be inserted using endoscopy into the tumor. The sources release by recoil into the tumor short-lived alpha-emitting atoms

Study Details

This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V5. The secondary objectives of the study are to: * Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival. * Assess pain control * Assess rate of surgical resection in Cohort 1.

Key Dates

Start date

Jun 17, 2025

Status verified

Oct 2025

Primary completion

Oct 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Patients with locally advanced pancreatic adenocarcinoma
  Patients will begin mFOLFIRINOX or Gemcitabine/Abraxane treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.
• Experimental: Patients with metastatic pancreatic adenocarcinoma
  Patients will begin mFOLFIRINOX or Gemcitabine/Abraxane treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.

Primary Outcome Measure

Safety -Serious adverse events [ Time Frame: From Day 0 ,up to 24 months. ]

Central Contacts

• Liron Dimnik
  +972-2-3737-7000
  [email protected]

Locations (13)

Find similar trials in Gilbert, AZ

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