Skin CancerNCT03737734
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)
A study testing Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Skin Cancer and Mucosal Neoplasm of Oral Cavity, run by Alpha Tau Medical LTD. at 1 site in Israel.
Trial summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer, Mucosal Neoplasm of Oral Cavity, Soft Tissue Neoplasm
- 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
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Dec 2018to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma.
- Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
- Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.
- Subjects' ECOG Performance Status Scale is < 2.
- Subjects' life expectancy is more than 6 months.
- Platelet count ≥100,000/mm3.
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- International normalized ratio of prothrombin time ≤1.8.
- Creatinine ≤1.9 mg/dL.
- 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 of Keratoacanthoma histology.
- 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.
- High probability of protocol non-compliance (in opinion of investigator)
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Davidof Cancer Institution at the Rabin Medical Center Israel
Petah Tikva, 49100
About this study
Official title: A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
Read the detailed description
This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy 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.
Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.
Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).
- Being tested
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Keywords
- Squamous Cell Carcinoma, SCC, Skin Cancer, Skin metastasis, HNSCC, Carcinoma, Squamous, CMN, Basal cell carcinoma, Superficial sarcoma, Kaposi sarcoma, Alpha radiation, Cutaneous lesion, Tongue cancer, Lip cancer, Brachytherapy
- Medical subject headings
- Skin Neoplasms, Soft Tissue Neoplasms, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Basal Cell, Sarcoma, Kaposi, Tongue Neoplasms, Lip 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
An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the 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.
Tumor response to DaRT
Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Measured: 9-11 weeks post DaRT insertion
Adverse Events
The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.
Measured: Up to 24 Months
Secondary outcomes (6)
Reduction in tumor volume
based on imaging
Measured: 9-11 weeks post DaRT insertion
DaRT seeds placement
Assessment by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion
Measured: Day of insertion procedure
Change in quality of life
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score
Measured: Day 15, Day 30, Day 70, Day 180 post DaRT insertion
Change in quality of life
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score
Measured: Day 30, Day 70, Day 180 post DaRT insertion
Adverse Events
All Adverse Events (AE) related and unrelated to the study treatment
Measured: Up to 24 Months
Progression Free Survival
Time elapsed from response to disease progression
Measured: 24 months post DaRT insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start31 Dec 2018
- Primary completionDec 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 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noga Kurman, MD, Principal investigator, Davidof Cancer Institution at Rabin Medical Center Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737734
- Sponsor's protocol ID
- CTP-CMN-02
- Status last verified
- Nov 2025
- First submitted
- 8 Nov 2018
- Last updated
- 6 Apr 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 6 Apr 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, Mucosal or Superficial Soft Tissue Neoplasia
- ClinicalTrials.gov ID
- NCT03737734
- Acronym / sponsor ID
- CTP-CMN-02
- Keywords
- Squamous Cell Carcinoma, SCC, Skin Cancer, Skin metastasis, HNSCC, Carcinoma, Squamous, CMN, Basal cell carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Nov 2018 (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 superficial cutaneous, mucosal or soft tissue neoplasia
Detailed description
This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy 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.
Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.
Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency 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 | 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 (10 listed)
- Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma.
- Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
- Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.
- Subjects' ECOG Performance Status Scale is < 2.
- Subjects' life expectancy is more than 6 months.
Key exclusion criteria (6 listed)
- Subject has a tumor of Keratoacanthoma histology.
- 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.
- High probability of protocol non-compliance (in opinion of investigator)
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: DaRTAn intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms. | Device | DaRT Seeds |
Primary outcome
Tumor response to DaRT
Time frame: 9-11 weeks post DaRT insertion
Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Adverse Events
Time frame: Up to 24 Months
The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.
6 secondary outcomes
Reduction in tumor volume
Time frame: 9-11 weeks post DaRT insertion
DaRT seeds placement
Time frame: Day of insertion procedure
Change in quality of life
Time frame: Day 15, Day 30, Day 70, Day 180 post DaRT insertion
Change in quality of life
Time frame: Day 30, Day 70, Day 180 post DaRT insertion
Adverse Events
Time frame: Up to 24 Months
Progression Free Survival
Time frame: 24 months post DaRT 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 6 Apr 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. This study is not recruiting at the moment.
Noga Kurman, MD principal investigator
Davidof Cancer Institution at Rabin Medical Center Israel
1 site 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 Skin Cancer and Mucosal Neoplasm of Oral Cavity, 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 10 inclusion and 6 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 6 Apr 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?
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?
Tumor response to DaRT (time frame: 9-11 weeks post DaRT insertion). 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 6 Apr 2026.