Squamous Cell CarcinomaDaRTNCT06615635
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous SCC for Immunocompromised Patients
A study testing DaRT seeds in people with Squamous Cell Carcinoma and Alpha Radiation, run by Alpha Tau Medical LTD. at 11 sites in 2 countries.
Trial summary
This is a multi-center clinical study enrolling up to 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma, Alpha Radiation, Immunocompromised
- What is being tested?
- DaRT seeds
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 1 Jan 2026to 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
- 1. Patients with cutaneous SCC histologically confirmed 2. Histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment 3. Immunocompromised due to any primary or secondary immunodeficiencies Measurable disease according to RECIST v 1.1.
- 4. Patient able and willing to undergo multiple CT scans 5. Tumor size ≤7 cm, at the longest diameter. 6. Single lesion per subject. 7. Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds. Targets will be deemed technically amenable for complete coverage if there are entry and exit vectors for placement that are not hindered by bone or major vessels or other vital organs (eg. eye) as decided by treating physician and sponsor.
- 8. Interstitial implant indication validated by multidisciplinary team. 9. ECOG Performance Status ≤2. 10. Life expectancy ≥12 months. 11. Subjects male/ female ≥18. 12. Willing and have the ability to provide signed Informed Consent. 13. Patients, male and female, with reproductive potential (including women who are menopausal for less than a year and not surgically sterilized), must practice acceptable effective methods of birth control, such as barrier methods, condom or diaphragm with spermicide or abstinence. Birth control should be continued for 1 year after the DaRT insertion visit.
- 14. Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.
- 15. Blood tests values:
- Platelets ≥100,000 mm3,
Show all 13Show fewer
- Total bilirubin ≤ 1.5xULN,
- AST ≤2.5xULN,
- SGOT ≤2.5xULN,
- SGPT ≤2.5xULN,
- Alkaline Phosphatase ≤2.5xULN.
- Creatinine Clearance ≥30 ml/min.
- INR or Prothrombin time ≤1.5xULN.
Who cannot join
- 1. Distant or nodal metastatic disease (according to the TNM staging system - N+ or M1 patients are excluded).
- 2. T4 disease 3. extensive PNI 4. Previously untreated cutaneous SCC 5. Mucosal SCC. 6. Inability to fully cover the entire volume with DaRT seeds 7. Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs 8. Inability or unwillingness to undergo multiple CT scans 9. Patients receiving any of the following within 4 weeks of enrollment:
- Antineoplastic systemic chemotherapy or biological therapy
- Immunotherapy
- Investigational agents other than the study intervention
- Radiation therapy
Show all 14Show fewer
- Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial.
- 10. Longest tumor diameter >7 cm. 11. Tumor with keratoacanthoma histology. 12. Known hypersensitivity to any component of treatment. 13. Clinically significant cardiovascular disease e.g., cardiac failure of New York Heart Association class III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, history of myocardial infarction in the last 12 months.
- 14. Any medical or Psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to tolerate treatment and to adhere to the clinical trial protocol.
- 15. Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and/or interpretation of treatment safety or effectiveness.
- 16. High probability of protocol non-compliance (in opinion of investigator). 17. 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.
- 18. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- 19. Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry and for 1 year after the DaRT insertion visit.
- 20. Breastfeeding or pregnant women 21. Tattoos scars, body jewelry (e.g., nose rings) or other identifying marks which cannot be adequately hidden on digital photos or other identifying marks which cannot be adequately hidden on digital photos
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
United States10 sites, 10 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30308
Mohammad K Khan, MD, 404-778-3473, m.k.khan@emory.edu
Stacie K Hitchcook, 4047783473, stitch2@emory.edu
- Not yet recruiting
Integrity Research Clinical Associates
Boca Raton, Florida, 33445
John Strasswimmer, Md, strasswimmer@gmail.com
Renzo Puente, rpuente@integriresearch.com
- Recruiting
Bassett Healthcare
Cooperstown, New York, 13326
Timothy Korytko, MD, 607-547-3989, timothy.korytko@bassett.org
Peggy Cross, peggy.cross@bassett.org
- Recruiting
Banner Health
Gilbert, Arizona, 35234
Michael Samuels, MD, 480-256-4488, Michael.Samuels2@bannerhealth.com
- Recruiting
Hollywood Dermatology
Hollywood, Florida, 33201
Eduardo Weiss, MD, 561-958-3116, EWeissSCR@gmail.com
Lucy Vargas, L.Vargas@dermcaremgt.com
- Not yet recruiting
Palm Beach Dermatology Group
Palm Beach, Florida, 33848
Adam S Plotkin, MD, 561-559-1516, adam@adamplotkin.com
- Recruiting
Us Dermatology Parthners
Phoenix, Arizona, 85006
Nathalie C Zeitouni, MD, 716-861-2159, nathaliezeitouni@arizona.edu
- Recruiting
Alliance Dermatology
Phoenix, Arizona, 85032
Snehal P. Amin, MD, 212-661-3376, DrAmin@MDCSnyc.com
- Not yet recruiting
Day Star Skin Cancer Center
Poinciana, Florida, 33445
Neil Sandhu, MD, sandhu.neil@gmail.com
Angie Galicia, 13866283376, agalicia@annexusderm.com
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Timothy Malouff, MD, 215-990-6189, Malouff.Timothy@mayo.edu
Israel1 site, 1 recruiting
- Not yet recruiting
Hadassah Medical Center
Jerusalem, 9112001
Sivan Shefer, MD, Sivan_sheffer@yahoo.com
About this study
Official title: A Single Arm, Open Label Clinical Study to Assess the Safety and Efficacy of Intratumoral Alpha DaRT224 for the Treatment of Immunocompromised Patients With Cutaneous Squamous Cell Carcinoma
This is a multi-center clinical study enrolling up to 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy. Secondary objectives are to:
- Determine Progression Free Survival (PFS) up to 12 months after Alpha DaRT sources insertion.
- Assess Overall Survival (OS) of patients treated with DaRT up to 12 months.
- Assess Local control up to 12 months after DaRT insertion.
Read the detailed description
This study is a multicenter, single arm, open label clinical study to assess the efficacy and safety of intratumoral Alpha DaRT-224 for the treatment of of Immunocompromised Patients with Cutaneous Squamous Cell Carcinoma
The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. Alpha DaRT sources will be inserted into Cutaneous Squamous Cell Carcinoma tumors and will be removed following 14-21 days.
The The objective response rate (ORR), which is calculated as the percent of patients achieving an objective response. Best overall response using the Response Evaluation Criteria in Solid Tumors guidelines (RECIST v1.1). Best overall response is assessed starting from DaRT removal. Safety will be assessed based on the cumulative incidence rate, severity and outcome of device related Adverse Events (AEs). Classification of AEs will be done according to CTCAE v5.
- Conditions
- Squamous Cell Carcinoma, Alpha Radiation, Immunocompromised, Carcinoma, Squamous, Skin Cancer, Brachytherapy
- Being tested
- DaRT seeds
- Medical subject headings
- Carcinoma, Squamous Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaRT seedsDevice
Also called DaRT
Diffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients
| Study group | Role | What they receive |
|---|---|---|
| DaRT seeds | Experimental | Diffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients Receives: Device: DaRT seeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
- Assessment of the objective response rate (ORR) determined by the best overall response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
Measured: From Day 14 until 52 weeks
Secondary outcomes (3)
Progression Free Survival
- Determine Progression Free Survival (PFS) up to 12 months after DaRT seed insertion.
Measured: Up to 12 months after DaRT seed insertion
Overall Survival
- Assess Overall Survival (OS) of patients treated with DaRT up to 12 months.
Measured: Up to 12 months after DaRT seed insertion
Local control
- Assess Local control up to 12 months after DaRT insertion.
Measured: Up to 12 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 posted26 Sep 2024
- Study start1 Jan 2026
- 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 Squamous Cell CarcinomaStudies 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
- Model description
- This is an International Multicenter, Single Arm, Open Label with DaRT for the treatment of Immunocompromised Cutaneous Squamous Cell Carcinoma
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT06615635
- Sponsor's protocol ID
- CTP-SCC-04
- Acronym
- DaRT
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2024
- Last updated
- 15 Jul 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label Clinical Study to Assess the Safety and Efficacy of Intratumoral Alpha DaRT224 for the Treatment of Immunocompromised Patients With Cutaneous Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06615635
- Acronym / sponsor ID
- DaRT / CTP-SCC-04
- Conditions
- Squamous Cell Carcinoma, Alpha Radiation, Immunocompromised, Carcinoma, Squamous, Skin Cancer, Brachytherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Sep 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 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy. Secondary objectives are to:
- Determine Progression Free Survival (PFS) up to 12 months after Alpha DaRT sources insertion.
- Assess Overall Survival (OS) of patients treated with DaRT up to 12 months.
- Assess Local control up to 12 months after DaRT insertion.
Detailed description
This study is a multicenter, single arm, open label clinical study to assess the efficacy and safety of intratumoral Alpha DaRT-224 for the treatment of of Immunocompromised Patients with Cutaneous Squamous Cell Carcinoma
The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. Alpha DaRT sources will be inserted into Cutaneous Squamous Cell Carcinoma tumors and will be removed following 14-21 days.
The The objective response rate (ORR), which is calculated as the percent of patients achieving an objective response. Best overall response using the Response Evaluation Criteria in Solid Tumors guidelines (RECIST v1.1). Best overall response is assessed starting from DaRT removal. Safety will be assessed based on the cumulative incidence rate, severity and outcome of device related Adverse Events (AEs). Classification of AEs will be done according to CTCAE v5.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an International Multicenter, Single Arm, Open Label with DaRT for the treatment of Immunocompromised Cutaneous Squamous Cell Carcinoma
| Arm | Type | Receives |
|---|---|---|
| DaRT seeds | Experimental | Device: DaRT seedsDiffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Patients with cutaneous SCC histologically confirmed 2. Histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment 3. Immunocompromised due to any primary or secondary immunodeficiencies Measurable disease according to RECIST v 1.1.
- 4. Patient able and willing to undergo multiple CT scans 5. Tumor size ≤7 cm, at the longest diameter. 6. Single lesion per subject. 7. Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds. Targets will be deemed technically amenable for complete coverage if there are entry and exit vectors for placement that are not hindered by bone or major vessels or other vital organs (eg. eye) as decided by treating physician and sponsor.
- 8. Interstitial implant indication validated by multidisciplinary team. 9. ECOG Performance Status ≤2. 10. Life expectancy ≥12 months. 11. Subjects male/ female ≥18. 12. Willing and have the ability to provide signed Informed Consent. 13. Patients, male and female, with reproductive potential (including women who are menopausal for less than a year and not surgically sterilized), must practice acceptable effective methods of birth control, such as barrier methods, condom or diaphragm with spermicide or abstinence. Birth control should be continued for 1 year after the DaRT insertion visit.
- 14. Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.
Key exclusion criteria (14 listed)
- 1. Distant or nodal metastatic disease (according to the TNM staging system - N+ or M1 patients are excluded).
- 2. T4 disease 3. extensive PNI 4. Previously untreated cutaneous SCC 5. Mucosal SCC. 6. Inability to fully cover the entire volume with DaRT seeds 7. Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs 8. Inability or unwillingness to undergo multiple CT scans 9. Patients receiving any of the following within 4 weeks of enrollment:
- 10. Longest tumor diameter >7 cm. 11. Tumor with keratoacanthoma histology. 12. Known hypersensitivity to any component of treatment. 13. Clinically significant cardiovascular disease e.g., cardiac failure of New York Heart Association class III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, history of myocardial infarction in the last 12 months.
- 14. Any medical or Psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to tolerate treatment and to adhere to the clinical trial protocol.
- 15. Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and/or interpretation of treatment safety or effectiveness.
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 seedsAlso: DaRTDiffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients | Device | DaRT seeds |
Primary outcome
objective response rate
Time frame: From Day 14 until 52 weeks
• Assessment of the objective response rate (ORR) determined by the best overall response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
3 secondary outcomes
Progression Free Survival
Time frame: Up to 12 months after DaRT seed insertion
Overall Survival
Time frame: Up to 12 months after DaRT seed insertion
Local control
Time frame: Up to 12 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 15 Jul 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
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DaRT seeds in people with Squamous Cell Carcinoma and Alpha Radiation, run by Alpha Tau Medical LTD. at 11 sites in 2 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 13 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 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, 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 (+972-2-3737-210, LironD@alphatau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: From Day 14 until 52 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 15 Jul 2026.