Pancreatic CancerNCT06698458
Alpha Radiation Emitters (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
A study testing Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by Alpha Tau Medical LTD. at 15 sites in 3 countries.
Trial summary
This is a multi-center clinical study enrolling up to 50 participants. 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer
- What is being tested?
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 17 Jun 2025to Dec 2026
- 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 newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and/or cytologically proven newly diagnosed metastatic pancreatic adenocarcinoma (Cohort 2).
- Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion
- Target lesion is technically amenable for Alpha DaRT sources implantation.
- Measurable lesion per RECIST (version 1.1) criteria
- Lesion size ≤ 5 cm in the longest diameter
- Interstitial radiation indication validated by a multidisciplinary team.
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- ECOG Performance Status Scale 0 -2
- 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
- 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 initiation of Alpha DaRT therapy.
- 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 DaRT insertion.
Who cannot join
- For Cohort 1 only: Borderline unresectable pancreatic cancer, and/or fit for surgical exploration unless patient refuses surgery.
- For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy, immunotherapy, etc.
- 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.
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- 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 DaRT insertion.
- 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 DaRT insertion
- Patients who are at high risk of complications from radiation due to genetic conditions/mutations, inflammatory bowel disease, or connective tissue disease.
Trial locations and contacts
15 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 3 countries
United States13 sites, 13 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30308
MD
- Recruiting
Bassett Healthcare Network
Cooperstown, New York, 13326
Timothy Korytko, MD, 607-547-3089, timothy.korytko@bassett.org
Peggy Cross, peggy.cross@bassett.org
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Prathab Devaraj, MD, Prathab.Devaraj@bannerhealth.com
Angel Tameron, 480-256-3311, BMDACCStudyStartup@bannerhealth.com
- Not yet recruiting
City of Hope
Goodyear, Arizona, 85338
Toufic Kachaamy, MD, tkachaamy@coh.org
Miranda Miranda Qian, (626) 218-3533, lqian@coh.org
- Not yet recruiting
Texas Oncology
Houston, Texas, 75251
John Hardaway, MD, 281-822-3390, john.hardaway@usoncology.com
Amber Graham, 972-480-3285, Amber.graham@usoncology.com
- Recruiting
Baylor College of Medicine
Houston, Texas, 77054
Benjamin Leon Musher, MD, blmusher@bcm.edu
Monica Francois, 713-798-4667, monica.francois@bcm.edu
- Recruiting
University Cancer and Diagnostic
Houston, Texas, 77089
Mark D'Andrea, MD, 936-223-1379, mmmeead@aol.com
Jo Ann Ramirez, 9362231379, jramirez@universitycancercenters.com
- Not yet recruiting
Cedars-Sinai
Los Angeles, California, 90048
Mitchell Kamrava, MD, Mitchell.Kamrava@cshs.org
Amit Gupta, 310.423.1270, amit.gupta2@cshs.org
- Recruiting
NYU Langone Health
New York, New York, 10016
Gonda Tamas Adam, MD, Tamas.Gonda@nyulangone.org
NYU NYU, 212-263-6165, ct.gov@nyulangone.org
- Not yet recruiting
Lenox hill Hospital
New York, New York, 10075
Elliot Newman, MD, enewman4@northwell.edu
- Not yet recruiting
Advent Health Cancer Institute
Orlando, Florida, 32804
Sharona Ross, MD, mysharonaross@gmail.com
Amber Barrick, amber.barrick@adventhealth.com
- Recruiting
Honor Health
Scottsdale, Arizona, 85258
Erkut Borazanci, MD, eborazanci@honorhealth.com
Amy Malenesk, amalensek@honorhealth.com
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Rafi Kabarriti, MD, rkabarri@montefiore.org
Rikin Gandhi, rikin.gandhi@einsteinmed.edu
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec
Corey Miller, MD, 514-340-8144, corey.miller@mcgill.ca
Chadi Zakaria, Ph.D., 514-340-8222 Ext 23293, chadi.zakaria.ccomtl@ssss.gouv.qc.ca
Israel1 site, 1 recruiting
- Recruiting
Hadassah Ein Kerem
Jerusalem
Aron Popovzer, MD, Aronp@hadassah.org.il
Hanna Lea Knafou, 972-2-6776709, hannalea@hadassah.org.il
About this study
Official title: A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
This is a multi-center clinical study enrolling up to 50 participants. 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 V6. 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.
Read the detailed description
This study will be a prospective, interventional, open label, two cohort, multiple center study to assess the efficacy of Alpha DaRT in combination with chemotherapy. Eligible patients with newly diagnosed pancreatic cancer will be categorized into one of the following two cohorts according to their disease state at baseline and the chemotherapy choice at the physician's discretion:
- Cohort 1: Locally advanced pancreatic cancer treated with mFOLFIRINOX or Gemcitabine/Abraxane
- Cohort 2: Metastatic pancreatic cancer treated with mFOLFIRINOX or Gemcitabine/Abraxane
Patients will begin mFOLFIRINOX or Gemcitabine/Abraxane treatment depending on their assigned cohort and will undergo DaRT placement during the first 4 cycles of chemotherapy.
- Being tested
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Keywords
- Alpha radiation, pancreatic cancer, Pancreatic Adenocarcinoma, Unresectable Pancreatic 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.
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)Device
Also called DaRT
DaRT source will be inserted using endoscopy into the tumor. The sources release by recoil into the tumor short-lived alpha-emitting atoms
| Study group | Role | What they receive |
|---|---|---|
| Patients with locally advanced pancreatic adenocarcinoma | Experimental | 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. Receives: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) |
| Patients with metastatic pancreatic adenocarcinoma | Experimental | 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. Receives: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety -Serious adverse events
The primary endpoint is the incidence , rate and severity of treatment- emergent Adverse Events (TEAS) graded according to CTCAE V6.0.
Measured: From Day 0 ,up to study termination
Secondary outcomes (4)
Overall survival
Overall survival - measured as the time from DaRT insertion to death or last survival follow-up.
Measured: From Day 1
Progression-free survival
measured as the time from DaRT insertion to the first documentation of progression, excluding surgery enabled after tumor was deemed resectable or up to last-follow-up up.
Measured: From Day 1
Complete or partial response
30 days and 2 months post-procedure as compared to baseline based on average pain scale using BPI-SF
Measured: 30 days and 2 months post- procedure
For Cohort 1 only: Percentage of locally advanced
patients with tumors that became surgically resectable after DaRT treatment
Measured: 6 and 24 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start17 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 25 patients in each cohort for a total of 50 subjects.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liron Dimnik, Study director, Alpha Tau Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698458
- Sponsor's protocol ID
- CTP-PANC-09
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06698458
- Acronym / sponsor ID
- CTP-PANC-09
- Keywords
- Alpha radiation, pancreatic cancer, Pancreatic Adenocarcinoma, Unresectable Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Nov 2024 (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.
This is a multi-center clinical study enrolling up to 50 participants. 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 V6. 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.
Detailed description
This study will be a prospective, interventional, open label, two cohort, multiple center study to assess the efficacy of Alpha DaRT in combination with chemotherapy. Eligible patients with newly diagnosed pancreatic cancer will be categorized into one of the following two cohorts according to their disease state at baseline and the chemotherapy choice at the physician's discretion:
- Cohort 1: Locally advanced pancreatic cancer treated with mFOLFIRINOX or Gemcitabine/Abraxane
- Cohort 2: Metastatic pancreatic cancer treated with mFOLFIRINOX or Gemcitabine/Abraxane
Patients will begin mFOLFIRINOX or Gemcitabine/Abraxane treatment depending on their assigned cohort and will undergo DaRT placement during the first 4 cycles of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 25 patients in each cohort for a total of 50 subjects.
| Arm | Type | Receives |
|---|---|---|
| Patients with locally advanced pancreatic adenocarcinoma | Experimental | Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)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. |
| Patients with metastatic pancreatic adenocarcinoma | Experimental | Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)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. |
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 newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and/or cytologically proven newly diagnosed metastatic pancreatic adenocarcinoma (Cohort 2).
- Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion
- Target lesion is technically amenable for Alpha DaRT sources implantation.
- Measurable lesion per RECIST (version 1.1) criteria
- Lesion size ≤ 5 cm in the longest diameter
Key exclusion criteria (14 listed)
- For Cohort 1 only: Borderline unresectable pancreatic cancer, and/or fit for surgical exploration unless patient refuses surgery.
- For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy, immunotherapy, etc.
- 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.
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 |
|---|---|---|
| Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)Also: DaRTDaRT source will be inserted using endoscopy into the tumor. The sources release by recoil into the tumor short-lived alpha-emitting atoms | Device | Patients with locally advanced pancreatic adenocarcinoma, Patients with metastatic pancreatic adenocarcinoma |
Primary outcome
Safety -Serious adverse events
Time frame: From Day 0 ,up to study termination
The primary endpoint is the incidence , rate and severity of treatment- emergent Adverse Events (TEAS) graded according to CTCAE V6.0.
4 secondary outcomes
Overall survival
Time frame: From Day 1
Progression-free survival
Time frame: From Day 1
Complete or partial response
Time frame: 30 days and 2 months post- procedure
For Cohort 1 only: Percentage of locally advanced
Time frame: 6 and 24 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 27 Aug 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.
Liron Dimnik study director
Alpha Tau Medical
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by Alpha Tau Medical LTD. at 15 sites in 3 countries.
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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada, Israel. 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?
Safety -Serious adverse events (time frame: From Day 0 ,up to study termination). 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 27 Aug 2026.