Skin CancerNCT04068155
Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors
A study testing DaRT- Diffusing Alpha-emitters Radiation Therapy in people with Skin Cancer and Cutaneous Tumor, run by Alpha Tau Medical LTD. at 2 sites in France.
Trial summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer, Cutaneous Tumor, Cutaneous Metastasis
- What is being tested?
- DaRT- Diffusing Alpha-emitters Radiation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Apr 2022to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:
- SCC
- BCC
- Lentigo maligna melanoma (Dubreuilh melanoma)
- Carcinosarcoma
- Acceptable tumor locations include the following:
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- Skin (facial, scalp, extremities, torso)
- Lips
- Eyelids
- Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
- Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.
- Measurable disease according to RECIST v1.1.
- Subjects over 18 years old.
- Subjects' ECOG Performance Status Scale is < 2.
- Subjects' life expectancy is more than 6 months.
- Platelet count ≥100,000/mm3.
- International normalized ratio of prothrombin time ≤1.8.
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
- Subjects are willing to sign an informed consent form
Who cannot join
- Subject has a tumor with histology of one of the following:
- Keratoacanthoma
- Merkel cell carcinoma
- Sarcoma other than carcinosarcoma
- Metastatic disease (according to the TNM staging system - M1 patients are excluded)
- 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).
- Subjects not willing to sign an informed consent.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amnon Gat contact
France2 sites, 2 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble, 38700
M. Camille Verry, MD, 33 (0) 476765435, cverry@chu.grenoble.fr
- Recruiting
Centre Léon Bérard
Lyon, 69008
POMMIER Pascal, MD, 33 (0) 478785166, pascal.pommier@lyon.unicancer.fr
About this study
Official title: A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors
Read the detailed description
This will be a prospective, open label, single arm, multi- center study, assessing the safety and effectiveness of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.
This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.
Cutaneous lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.
Reduction in tumor size 9-11 weeks following DaRT insertion will be assessed. Safety will be assessed by the frequency, severity and causality of all Adverse Events (AE).
- Conditions
- Skin Cancer, Cutaneous Tumor, Cutaneous Metastasis
- Being tested
- DaRT- Diffusing Alpha-emitters Radiation Therapy
- Keywords
- Squamous Cell Carcinoma, Basal Cell Carcinoma, Skin Cancer, Skin Metastasis, Superficial Sarcoma, Alpha Radiation, Cutaneous Lesion, Brachytherapy, Radiotherapy, Lentigo maligna melanoma, Carcinosarcom, scalp cancer, Lip cancer, Eyelid cancer, SCC
- Medical subject headings
- Skin Neoplasms, Carcinoma, Squamous Cell, Carcinoma, Basal Cell, Lip Neoplasms, Eyelid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaRT- Diffusing Alpha-emitters Radiation TherapyDevice
Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles
| Study group | Role | What they receive |
|---|---|---|
| DaRT Seeds Intratumoral Diffusing alpha-emitters | Experimental | An intratumoral insertion of securely fixed seeds loaded with Radium-224. The seeds release by recoil short-lived alpha-emitting atoms into the tumor. Receives: Device: DaRT- Diffusing Alpha-emitters Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective response rate to DaRT treatment
Assessment of tumor response rate using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Measured: up to 9-11 weeks
Secondary outcomes (5)
Tumor volume
Assessment of the reduction in tumor volume based on imaging tests
Measured: up to 9-11 weeks
DaRT seeds placement
Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging
Measured: Day of DaRT insertion procedure
Change in quality of life as assessed by the Skindex-16 questionnaire
Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skindex-16 questionnaire
Measured: up to 9-11 weeks
Disease-Free Survival (DFS) rate
Assessment of Disease-Free Survival
Measured: up to 24 months
Change in quality of life as assessed by the Skin Cancer Index (SCI) questionnaire
Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skin Cancer Index (SCI) questionnaire.
Measured: up to 9-11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Apr 2022
- 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 Skin 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Pascal POMMIER, Principal investigator, Centre Leon BerardPr Jean Michel HANNOUN LEVI, Principal investigator, Antoine Lacassagne Cancer CenterDr Camille VERRY, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068155
- Sponsor's protocol ID
- CTP-MCT-00
- Status last verified
- Nov 2025
- First submitted
- 19 Aug 2019
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors
- ClinicalTrials.gov ID
- NCT04068155
- Acronym / sponsor ID
- CTP-MCT-00
- Conditions
- Skin Cancer, Cutaneous Tumor, Cutaneous Metastasis
- Keywords
- Squamous Cell Carcinoma, Basal Cell Carcinoma, Skin Cancer, Skin Metastasis, Superficial Sarcoma, Alpha Radiation, Cutaneous Lesion, Brachytherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 28 Aug 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 Malignant Cutaneous Tumors
Detailed description
This will be a prospective, open label, single arm, multi- center study, assessing the safety and effectiveness of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.
This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.
Cutaneous lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.
Reduction in tumor size 9-11 weeks following DaRT insertion will be assessed. Safety will be assessed by the frequency, severity and causality of all Adverse Events (AE).
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 Intratumoral Diffusing alpha-emitters | Experimental | Device: DaRT- Diffusing Alpha-emitters Radiation TherapyAn intratumoral insertion of securely fixed seeds loaded with Radium-224. The seeds release by recoil short-lived alpha-emitting atoms into the tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:
- Acceptable tumor locations include the following:
- Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
- Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.
- Measurable disease according to RECIST v1.1.
Key exclusion criteria (11 listed)
- Subject has a tumor with histology of one of the following:
- Metastatic disease (according to the TNM staging system - M1 patients are excluded)
- 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.).
- 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.
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- Diffusing Alpha-emitters Radiation TherapySeed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles | Device | DaRT Seeds Intratumoral Diffusing alpha-emitters |
Primary outcome
The objective response rate to DaRT treatment
Time frame: up to 9-11 weeks
Assessment of tumor response rate using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
5 secondary outcomes
Tumor volume
Time frame: up to 9-11 weeks
DaRT seeds placement
Time frame: Day of DaRT insertion procedure
Change in quality of life as assessed by the Skindex-16 questionnaire
Time frame: up to 9-11 weeks
Disease-Free Survival (DFS) rate
Time frame: up to 24 months
Change in quality of life as assessed by the Skin Cancer Index (SCI) questionnaire
Time frame: up to 9-11 weeks
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.
- Individual participant dataSharing planned: No
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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.
Amnon Gat contact
Dr Pascal POMMIER principal investigator
Centre Leon Berard
Pr Jean Michel HANNOUN LEVI principal investigator
Antoine Lacassagne Cancer Center
Dr Camille VERRY principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DaRT- Diffusing Alpha-emitters Radiation Therapy in people with Skin Cancer and Cutaneous Tumor, run by Alpha Tau Medical LTD. at 2 sites in France.
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 19 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: 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 2 sites in France. 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 (+972-2-373-7000, LironD@alphatau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The objective response rate to DaRT treatment (time frame: up to 9-11 weeks). 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.