NCT06755359

Brief Summary

A unique approach for cancer treatment including radioactive sources named Alpha DaRT sources: Ra - 224 coated onto stainless steel tubes inserted into the tumor for the treatment of Locally Advanced Pancreatic Cancer .

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pancreatic-cancer

Timeline
13mo left

Started Jan 2026

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

12 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jan 2026Jun 2027

First Submitted

Initial submission to the registry

December 19, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

December 19, 2024

Last Update Submit

December 1, 2025

Conditions

Pancreatic CancerLocally Advanced Pancreatic Cancer

Keywords

Alpha radiationpancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Safety - Serious adverse events

    Safety will be determined according to the overall incidence of device related SAEs with severity graded according to CTCAE v5.0 criteria

    from Day 0 , up to 12 months

Secondary Outcomes (5)

  • Efficacy - tumor response

    Day 0 , up to 12 months

  • Efficacy - overall survival

    Day 0 , up to 12 months

  • Efficacy - Progression-free survival

    Day 0 , up to 12 months

  • Efficacy - Percentage of R0/R1 resected patients

    Day 0 , up to 12 months

  • Efficacy - percentage of patients with tumors that became surgically respectable after DaRT treatment

    Day 0 , up to 12 months

Study Arms (1)

DaRT Seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Interventions

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)DEVICE

Radioactive sources named Alpha DaRT sources: Ra - 224 coated onto titanium tubes inserted into the tumor.

DaRT Seeds

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically and/or cytologically proven locally advanced pancreatic adenocarcinoma
  • Target lesion is technically amenable for Alpha DaRT sources implantation.
  • Measurable lesion per RECIST (version 1.1) criteria
  • Stable disease or tumor response per RECIST (version 1.1) criteria compared to before initiation of mFOLFIRINOX
  • Lesion size ≤ 5 cm in the longest diameter
  • Interstitial radiation indication validated by a multidisciplinary team which includes an oncologist, a radiation oncologist, radiologist, gastroenterologist and a surgeon specialized in pancreatic oncology in the case that a surgical emergency occurs during the procedure
  • Patients have received 8 - 12 cycles of mFOLFIRINOX
  • ECOG Performance Status Scale 0 - 1
  • Life expectancy is more than 6 months
  • WBC ≥ 3500/µl, granulocyte ≥ 1500/µl
  • Platelet count ≥60,000/µl
  • Creatinine ≤1.9 mg/dL
  • AST and ALT ≤ 2.5 X upper limit of normal (ULN)
  • INR \< 1.4 for patients not on Warfarin
  • Age ≥18 years old
  • +3 more criteria

You may not qualify if:

  • Concomitant immunotherapy within the past 4 weeks.
  • Patients with metastatic disease
  • Borderline unresectable pancreatic cancer, and/or cases fit for surgical exploration unless patient refuses surgery.
  • Known hypersensitivity to any of the components of the treatment.
  • Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
  • Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
  • Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.
  • Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.
  • Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
  • Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
  • High probability of protocol non-compliance (in opinion of investigator).
  • Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU de Bordeaux

Bordeaux, France

Location

CHU de Bordeaux

Bordeaux, France

Location

Centre Jean PERRIN - Clermont-Ferrand

Clermont-Ferrand, France

Location

Centre Georges François Leclerc Dijon

Dijon, France

Location

Centre Georges François Leclerc Dijon

Dijon, France

Location

Centre Georges François Leclerc Dijon

Dijon, France

Location

CHU Grenoble Alpes

Grenoble, France

Location

Hôpital Privé Mermoz - Lyon

Lyon, France

Location

Marseille

Marseille, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Poitiers

Poitiers, France

Location

Gustave Roussy Institute

Villejuif, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Liron Dimnik

CONTACT

972-54-2688602LironD@alphatau.com

Aviya Hoida

CONTACT

972-54-7869466aviyah@alphatau.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 1, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations

FR(12)