Pancreatic CancerNCT04002479
Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer
A study testing Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Pancreatic Cancer and Unresectable Pancreatic Cancer, run by Alpha Tau Medical LTD. at 2 sites in Canada.
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 years and older
- Conditions the study is for
- Pancreatic Cancer, Unresectable Pancreatic Cancer, 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
- 37 participants
- Where
- 2 sitesCanada
- Study dates
- 20 Oct 2020to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically proven locally advanced (Stage II or III) or metastatic (Stage IV) pancreatic, adenocarcinoma
- Inoperable pancreatic cancer due to at least one of the following: a) unresectability, b) metastatic disease, c) medically unfit for surgery
- ECOG performance status ≤ 2
- Measurable lesion per RECIST (version 1.1) criteria
- Maximum lesion of 4cm in the longest diameter (including primary tumor and regional lymph nodes)
- ≥ 18 years of age
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- Estimated life expectancy of at least 12 weeks
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test
- Subjects are willing to sign an informed consent
Who cannot join
- Prior chemotherapy does not exclude the patient
- Prior abdominal radiation therapy
- Concomitant chemotherapy or immunotherapy
- Borderline resectable pancreatic cancer and medically fit for surgery
- Connective tissue disease (scleroderma, lupus)
- Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
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- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
- 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)
- Patients not willing to sign an informed consent form
- Women who are pregnant or lactating
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec
Jewish General Hospital
Montreal, Quebec
About this study
Official title: A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters on 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, single-center, open label, single arm study. The study is designed to evaluate the feasibility, safety and preliminary efficacy of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for the treatment of advanced pancreatic cancer.
The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4-6 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure.
30 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. The patients will be monitored for a period of 24 months post insertion.
- Conditions
- Pancreatic Cancer, Unresectable Pancreatic Cancer, Metastatic Pancreatic Cancer, Pancreatic Adenocarcinoma
- Being tested
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Keywords
- pancreatic cancer, Unresectable Pancreatic Cancer, Metastatic Pancreatic Cancer, Pancreatic Adenocarcinoma, Pancreas Neoplasm, Alpha radiation, Pancreas Cancer, Pancreas Metastases
- 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
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: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - DaRT seed placement
Assessment of the DaRT seed placement within the tumor or less than 5 mm from the tumor using CT imaging on the day of DaRT insertion.
Measured: Day 0 (Day of insertion)
Safety - Adverse events
Assessment of the frequency, severity and causality of acute AEs and SAEs related to DaRT seeds insertion. AEs and SAEs will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0
Measured: 3 months
Safety - Adverse events
Assessment of the frequency, severity and causality of Late AEs and SAEs related to DaRT seeds insertion. AEs and SAEs will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The follow up will be carried out by phone calls every 2 months during the time between 3 to 24 months after DaRT seeds insertion
Measured: 3 to 24 months
Secondary outcomes (6)
Efficiency - Short-term effect
Assessment of the objective response rate (ORR) following DaRT seeds insertion using CT scan
Measured: 4-6 weeks after DaRT seeds insertion
Tissue damage evaluation
Measuring CA19-9 as a marker to tissue damage. Elevation during treatment, and reduction as a result of tumor ablation. Serum levels of CA 19-9 can be measured using chemiluminescent assay on an Unicel DxI 800 analyzer (BeckmanCoulter, Brea, CA, USA).
Measured: Day -14 to 60 days after insertion
Efficiency - Long-term effect
Assessment of the overall survival (OS) following DaRT seeds insertion
Measured: 2 years following DaRT seeds insertion
Stent durability
Stent durability will be assessed by the time elapsed from DaRT insertion to the need for follow-up referral for ERCP for stent change due to tumor ingrowth
Measured: Day of DaRT insertion up to 24 months.
Change in quality of life: EORTC-QLQ-C30
Assessment of patient reported health-related Quality of Life (QoL) outcomes after DaRT treatment, using QoL questionnaires EORTC-QLQ-C30 (version 3.0). Scale range in score from 0 (best) to 100(worst).
Measured: Day -14 to 60 days after insertion
Change in quality of life: QLQ-PAN26
Assessment of patient reported health-related Quality of Life (QoL) outcomes after DaRT treatment, using QoL questionnaires QLQ-PAN26. The module comprises 26 questions assessing pain, dietary changes, jaundice, altered bowel habit, emotional problems related to pancreatic cancer, and other symptoms (cachexia, indigestion, flatulence, dry mouth, taste changes).
Measured: Day -14 to 60 days after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start20 Oct 2020
- Primary completionOct 2026 (estimated)
- Study completionOct 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.
- 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Donath, MD, Principal investigator, Brachytherapy Service Centre Hospitalier de l'Université de MontrealCorey Miller, MD, Principal investigator, Division of Gastroenterology, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002479
- Sponsor's protocol ID
- AT-PANC-101
- Status last verified
- Nov 2025
- First submitted
- 16 Jun 2019
- Last updated
- 2 Dec 2025
- 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 2 Dec 2025. 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 on Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04002479
- Acronym / sponsor ID
- AT-PANC-101
- Conditions
- Pancreatic Cancer, Unresectable Pancreatic Cancer, Metastatic Pancreatic Cancer, Pancreatic Adenocarcinoma
- Keywords
- pancreatic cancer, Unresectable Pancreatic Cancer, Metastatic Pancreatic Cancer, Pancreatic Adenocarcinoma, Pancreas Neoplasm, Alpha radiation, Pancreas Cancer, Pancreas Metastases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Jun 2019 (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, single-center, open label, single arm study. The study is designed to evaluate the feasibility, safety and preliminary efficacy of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for the treatment of advanced pancreatic cancer.
The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4-6 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure.
30 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. The patients will be monitored for a period of 24 months post 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: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically and/or cytologically proven locally advanced (Stage II or III) or metastatic (Stage IV) pancreatic, adenocarcinoma
- Inoperable pancreatic cancer due to at least one of the following: a) unresectability, b) metastatic disease, c) medically unfit for surgery
- ECOG performance status ≤ 2
- Measurable lesion per RECIST (version 1.1) criteria
- Maximum lesion of 4cm in the longest diameter (including primary tumor and regional lymph nodes)
Key exclusion criteria (11 listed)
- Prior chemotherapy does not exclude the patient
- Prior abdominal radiation therapy
- Concomitant chemotherapy or immunotherapy
- Borderline resectable pancreatic cancer and medically fit for surgery
- Connective tissue disease (scleroderma, lupus)
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)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: Day 0 (Day of insertion)
Assessment of the DaRT seed placement within the tumor or less than 5 mm from the tumor using CT imaging on the day of DaRT insertion.
Safety - Adverse events
Time frame: 3 months
Assessment of the frequency, severity and causality of acute AEs and SAEs related to DaRT seeds insertion. AEs and SAEs will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0
Safety - Adverse events
Time frame: 3 to 24 months
Assessment of the frequency, severity and causality of Late AEs and SAEs related to DaRT seeds insertion. AEs and SAEs will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The follow up will be carried out by phone calls every 2 months during the time between 3 to 24 months after DaRT seeds insertion
6 secondary outcomes
Efficiency - Short-term effect
Time frame: 4-6 weeks after DaRT seeds insertion
Tissue damage evaluation
Time frame: Day -14 to 60 days after insertion
Efficiency - Long-term effect
Time frame: 2 years following DaRT seeds insertion
Stent durability
Time frame: Day of DaRT insertion up to 24 months.
Change in quality of life: EORTC-QLQ-C30
Time frame: Day -14 to 60 days after insertion
Change in quality of life: QLQ-PAN26
Time frame: Day -14 to 60 days after insertion
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 2 Dec 2025.
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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. This study is not recruiting at the moment.
David Donath, MD principal investigator
Brachytherapy Service Centre Hospitalier de l'Université de Montreal
Corey Miller, MD principal investigator
Division of Gastroenterology, Jewish General Hospital
2 sites in 1 country: 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 Unresectable Pancreatic Cancer, run by Alpha Tau Medical LTD. at 2 sites in Canada.
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 9 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - DaRT seed placement (time frame: Day 0 (Day of insertion)). The study lists 3 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 2 Dec 2025.