Malignant TumorNCT05781555
Alpha Radiation Emitters Device (DaRT) for Target Treatments of Malignant Tumors
A study testing Experimental: DaRT seeds in people with Malignant Tumor, run by Alpha Tau Medical LTD. at 1 site in Israel.
Trial summary
This study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumor
- What is being tested?
- Experimental: DaRT seeds
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Mar 2023to Apr 2027
- 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
- Subjects with any malignancy
- Subjects with a tumor size ≤ 7 centimeters in the longest diameter
- Subjects over 18 years old
- Subjects' life expectancy is more than 6 months
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after treatment.
- Subjects/Surrogate decision maker are willing to sign an informed consent form
Who cannot join
- Known hypersensitivity to any of the components of the treatment.
- 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.
- Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.
- 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.
- 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.
- High probability of protocol non-compliance (in opinion of investigator).
- Subjects/Surrogate decision maker not willing to sign an informed consent.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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 Prospective, Open Label, One Arm Study for a Compassionate Use of Diffusing Alpha Radiation Therapy
This study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.
Read the detailed description
This is an Open label, one arm, prospective study for Compassionate use for the treatment of malignant tumors. The study objectives are to collect data on the safety and efficacy of DaRT among patients who do not fit the entry of existing investigational trials.
The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.
- Conditions
- Malignant Tumor
- Being tested
- Experimental: DaRT seeds
- Keywords
- Tumor, Malignant Tumor, Cancer, Brachytherapy, Alpha emitting radiation, Compassionate treatment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: DaRT seedsDevice
DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. The study objectives are to collect data on the general safety and efficacy of DaRT among patients who do not fit the entry criteria of existing investigational trials.
| Study group | Role | What they receive |
|---|---|---|
| DaRT seeds | Experimental | Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds Receives: Device: Experimental: DaRT seeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the frequency, severity and causality of acute adverse events.
The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From Day 0 (DaRT insertion )
Secondary outcomes (1)
To assess the tumor response to DaRT treatment
The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Measured: 3 months after DaRT seed insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start22 Mar 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aron Popovzer, MD, Principal investigator, Hadassah University Hospital - Ein Kerem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781555
- Sponsor's protocol ID
- CTP- ALL-00
- Status last verified
- May 2026
- First submitted
- 26 Feb 2023
- Last updated
- 16 Jun 2026
- Results posted
- 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 Prospective, Open Label, One Arm Study for a Compassionate Use of Diffusing Alpha Radiation Therapy
- ClinicalTrials.gov ID
- NCT05781555
- Acronym / sponsor ID
- CTP- ALL-00
- Conditions
- Malignant Tumor
- Keywords
- Tumor, Malignant Tumor, Cancer, Brachytherapy, Alpha emitting radiation, Compassionate treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 23 Mar 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.
This study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.
Detailed description
This is an Open label, one arm, prospective study for Compassionate use for the treatment of malignant tumors. The study objectives are to collect data on the safety and efficacy of DaRT among patients who do not fit the entry of existing investigational trials.
The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed 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: Experimental: DaRT seedsIntratumoral 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 (6 listed)
- Subjects with any malignancy
- Subjects with a tumor size ≤ 7 centimeters in the longest diameter
- Subjects over 18 years old
- Subjects' life expectancy is more than 6 months
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after treatment.
Key exclusion criteria (8 listed)
- Known hypersensitivity to any of the components of the treatment.
- 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.
- Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.
- 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.
- 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.
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 |
|---|---|---|
| Experimental: DaRT seedsDaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. The study objectives are to collect data on the general safety and efficacy of DaRT among patients who do not fit the entry criteria of existing investigational trials. | Device | DaRT seeds |
Primary outcome
To assess the frequency, severity and causality of acute adverse events.
Time frame: From Day 0 (DaRT insertion )
The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0.
1 secondary outcome
To assess the tumor response to DaRT treatment
Time frame: 3 months after DaRT seed 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 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.
Aron Popovzer, MD principal investigator
Hadassah University Hospital - Ein Kerem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: DaRT seeds in people with Malignant Tumor, run by Alpha Tau Medical LTD. at 1 site in Israel.
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 6 inclusion and 8 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 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 (+972237377000, LironD@alphatau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the frequency, severity and causality of acute adverse events. (time frame: From Day 0 (DaRT insertion )). 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; AzTrials last refreshed its copy on 8 Nov 2026.