Pancreatic CancerNCT06026943
Alpha Radiation Emitters for the Treatment of Pancreatic Cancer for the Treatment of Locally Advanced Pancreatic Cancer
A study testing DaRT seeds insertion in people with Pancreatic Cancer and Unresectable Pancreatic Cancer, run by Alpha Tau Medical LTD. at 1 site in Italy.
Trial summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pancreatic Cancer, Unresectable Pancreatic Cancer, Pancreatic Adenocarcinoma
- What is being tested?
- DaRT seeds insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2026to Jan 2028
- Phase
- Interventional
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically proven NCCN locally advanced PC
- Patients must have i) received at least one line of chemotherapy (any kind) OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery, or the patient does not wish to go through surgery.
- DaRT indication validated by a multidisciplinary team.
- Measurable lesion per RECIST (version 1.1) criteria
- TC at Verona's center (not been over a month)
- Lesion size ≤ 5 cm in the longest diameter
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- Age ≥18 years old
- ECOG Performance Status Scale ≤ 2
- Life expectancy is more than 6 months
- WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
- Platelet count ≥60,000/μl
- Calculated or measured creatinine clearance ≥ 30cc/min. Calculated or measured creatinine clearance can be ≥ 40cc/min given stability of creatinine levels over the past three weeks (at least 1 test per week).
- AST and ALT ≤ 2.5 X upper limit of normal (ULN)
- INR < 1.4 for patients not on Warfarin
- Subjects are willing and able to sign an informed consent form
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.
- Patients must 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.
Who cannot join
- Concomitant chemotherapy or immunotherapy within the past 4 weeks
- Prior radiation therapy to the pancreas
- CA 19-9 > 1000 Units/ml
- Fit for surgical exploration unless the 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.
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- 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 (not including cholangitis) 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 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Chirurgia Generale e del Pancreas, Istituto del Pancreas
Verona
Salvatore Paiella, MD, 045-8124553
Erica Secchettin
About this study
Official title: A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer
Read the detailed description
This is a prospective, interventional, single-center, open label, single arm study. The study is designed to evaluate the feasibility and Safety of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer
The study will be comprised of a screening period, DaRT insertion visit, 3 months follow up per subject and 2 years for accrual and trial completion. The total duration of the study will be 24 months from the DaRT insertion procedure.
15 patients with a safety interim analysis after the 5 first patients . patients with advanced pancreatic cancer will be recruited by the investigational site.
Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion.
- Being tested
- DaRT seeds insertion
- Keywords
- pancreatic cancer, Unresectable Pancreatic Cancer, Pancreatic Adenocarcinoma, Alpha radiation, Pancreas Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaRT seeds insertionDevice
Also called Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms
| Study group | Role | What they receive |
|---|---|---|
| DaRT Seeds | Experimental | Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds Receives: Device: DaRT seeds insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- DaRT seed placement
Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging
Measured: Immediately following the insertion procedure
Safety- Adverse events, Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
Measured: from DaRT-insertion up to 48 hours
Secondary outcomes (4)
To evaluate the Efficacy of the Alpha DaRT seeds for locally advanced pancreatic cancer
Local control evaluation according to RECIST v1.1
Measured: 1 months and 3 months
To evaluate the Efficacy of the Alpha DaRT seeds by measuring the CA-19-9 markers levels
Change in CA 19-9 levels
Measured: 1 months and 3 months
Efficacy - to evaluate what is the percent of the Tumor Coverage by the Alpha DaRT seeds
Tumor Coverage
Measured: immediately following the insertion procedure]
Efficacy- Alpha DaRT seeds
Overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
Measured: from DaRT-insertion up to initiation of a possible postablation therapy or up to a maximum three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start6 May 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (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.
- More trials run by Alpha Tau Medical LTD.The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salvatore Paiella, MD, Principal investigator, Pancreas Institute - Integrated University Hospital of Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026943
- Sponsor's protocol ID
- CTP-PANC-03
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06026943
- Acronym / sponsor ID
- CTP-PANC-03
- Keywords
- pancreatic cancer, Unresectable Pancreatic Cancer, Pancreatic Adenocarcinoma, Alpha radiation, Pancreas Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 6 May 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 7 Sep 2023 (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.
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer
Detailed description
This is a prospective, interventional, single-center, open label, single arm study. The study is designed to evaluate the feasibility and Safety of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer
The study will be comprised of a screening period, DaRT insertion visit, 3 months follow up per subject and 2 years for accrual and trial completion. The total duration of the study will be 24 months from the DaRT insertion procedure.
15 patients with a safety interim analysis after the 5 first patients . patients with advanced pancreatic cancer will be recruited by the investigational site.
Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DaRT Seeds | Experimental | Device: DaRT seeds insertionIntratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically and/or cytologically proven NCCN locally advanced PC
- Patients must have i) received at least one line of chemotherapy (any kind) OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery, or the patient does not wish to go through surgery.
- DaRT indication validated by a multidisciplinary team.
- Measurable lesion per RECIST (version 1.1) criteria
- TC at Verona's center (not been over a month)
Key exclusion criteria (14 listed)
- Concomitant chemotherapy or immunotherapy within the past 4 weeks
- Prior radiation therapy to the pancreas
- CA 19-9 > 1000 Units/ml
- Fit for surgical exploration unless the patient refuses surgery
- Known hypersensitivity to any of the components of the 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 |
|---|---|---|
| DaRT seeds insertionAlso: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms | Device | DaRT Seeds |
Primary outcome
Feasibility- DaRT seed placement
Time frame: Immediately following the insertion procedure
Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging
Safety- Adverse events, Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
Time frame: from DaRT-insertion up to 48 hours
Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
4 secondary outcomes
To evaluate the Efficacy of the Alpha DaRT seeds for locally advanced pancreatic cancer
Time frame: 1 months and 3 months
To evaluate the Efficacy of the Alpha DaRT seeds by measuring the CA-19-9 markers levels
Time frame: 1 months and 3 months
Efficacy - to evaluate what is the percent of the Tumor Coverage by the Alpha DaRT seeds
Time frame: immediately following the insertion procedure]
Efficacy- Alpha DaRT seeds
Time frame: from DaRT-insertion up to initiation of a possible postablation therapy or up to a maximum three months
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 16 Jun 2026.
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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.
Salvatore Paiella, MD principal investigator
Pancreas Institute - Integrated University Hospital of Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DaRT seeds insertion in people with Pancreatic Cancer and Unresectable Pancreatic Cancer, run by Alpha Tau Medical LTD. at 1 site in Italy.
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 17 inclusion and 14 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 16 Jun 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 Italy. 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.
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 Liron Dimnik (+972-2-3737-7000, LironD@alphatau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility- DaRT seed placement (time frame: Immediately following the insertion procedure). The study lists 2 primary outcomes in all. 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 16 Jun 2026.