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Recurrent Squamous Cell CarcinomaNCT05323253

Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma

A study testing DaRT seeds in people with Recurrent Squamous Cell Carcinoma, run by Alpha Tau Medical LTD. at 28 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multi-center clinical study enrolling up to 86 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, as well as to assess the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Squamous Cell Carcinoma
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
86 participants
Where
28 sitesin 3 countries
Study dates
21 Sep 2022to 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

  • Patients with recurrent cutaneous SCC histologically confirmed who have failed at least first line standard of care therapy who are not indicated for surgery and standard radiation therapy, or non alpha radiation brachytherapy technologies, and for whom no curative systemic treatment is available
  • Central histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment
  • Measurable disease according to RECIST v 1.1.
  • Ability to undergo a CT scan
  • Tumor size ≤7 cm, at the longest diameter.
  • Single lesion per subject.
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  • 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).
  • Interstitial implant indication validated by multidisciplinary team.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
  • Life expectancy ≥12 months.
  • Subjects male/ female ≥18.
  • Willing and have the ability to provide signed Informed Consent.
  • 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 3 months after the DaRT insertion visit.
  • Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.
  • Blood tests values:
  • Leucocytes ≥3000mm3,
  • Absolute neutrophil count ≥1500mm3,
  • Platelets ≥100,000 mm3,
  • Total bilirubin ≤ 1.5xULN (upper limit of normal)
  • Aspartate Aminotransferase (AST) ≤2.5xULN,
  • Serum Glutamic-Oxaloacetic Transaminase (SGOT) ≤2.5xULN,
  • Serum Glutamic-Pyruvic Transaminase (SGPT) ≤2.5xULN,
  • Alkaline Phosphatase ≤2.5xULN.
  • Creatinine ≤ 2.0xULN or Creatinine Clearance ≥60 ml/min.
  • INR (International Normalized Ratio) or Prothrombin time ≤1.5xULN.

Who cannot join

  • Distant or nodal metastatic disease (according to the TNM [tumor, nodes , and metastases] staging system - N+ or M1 patients are excluded).
  • T4 disease or perineural spread of disease
  • Previously untreated cutaneous SCC indicated for surgery or radiation.
  • Mucosal, vulvar, anal and penile SCC.
  • Inability to fully cover the entire volume with DaRT seeds
  • Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs
Show all 26Show fewer
  • Inability to undergo a CT scan
  • Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
  • 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
  • Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial.
  • Longest tumor diameter >7 cm.
  • Tumor with keratoacanthoma histology.
  • Known hypersensitivity to any component of treatment.
  • 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.
  • 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.
  • Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and/or interpretation of treatment safety or effectiveness.
  • High probability of protocol non-compliance (in opinion of investigator).
  • 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.
  • 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.
  • Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry and for 3 months after the DaRT insertion visit.
  • Breastfeeding or pregnant women
  • Tattoos or other identifying marks which can not be adequately hidden on digital photos

Trial locations and contacts

28 sites in 3 countries.

28 sites in 3 countries

United States23 sites

  • New Mexico Cancer Center

    Albuquerque, New Mexico, 87109

  • Emory University

    Atlanta, Georgia, 30308

  • Dermatology of Seattle and Bellevue

    Bellevue, Washington, 98004

  • Bassett Healthcare Network

    Cooperstown, New York, 13326

  • Day Star Skin and Cancer Center

    DeLand, Florida, 32720

  • Integrity Research Clinical Associates

    Delray Beach, Florida, 33445

  • Palm beach Dermatology Group

    Delray Beach, Florida, 33484

  • Banner Health MD Anderson Phoenix

    Gilbert, Arizona, 85234

  • Schweiger Dermatology Group

    Hackensack, New Jersey, 07601

  • Hollywood Dermatology

    Hollywood, Florida, 33021

  • Gulf Coast Cancer Center

    Houston, Texas, 77008

  • University Cancer & Diagnostic Center

    Houston, Texas, 77089

  • UCLA

    Los Angeles, California, 90095

  • University of Miami

    Miami, Florida, 33101

  • Baptist Health South Florida MCI

    Miami, Florida, 33176

  • Dignity Health Cancer Institute

    Phoenix, Arizona, 85004

  • Alliance Dermatology

    Phoenix, Arizona, 85032

  • Northwell Health

    Queens, New York, 11375

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • New York Medical Skin Solutions

    Rockaway Park, New York, 11694

  • MDCS Dermatology

    Smithtown, New York, 11787

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Beer Dermatology

    West Palm Beach, Florida, 33401

Other trials in United States

Israel4 sites

  • Rambam Medical Center

    Haifa

  • Hadassah Medical Center

    Jerusalem, 9777605

  • Belinson-Rabin Medical Center

    Petah Tikva

  • Sheba Medical Center

    Ramat Gan

Other trials in Israel

Canada1 site

  • Princess Margaret Cancer Center

    Toronto, Ontario

Other trials in Canada

About this study

Official title: A Prospective International Multicenter, Pivotal, Single Arm, Open Label Clinical Study to Assess the Efficacy and Safety of Intratumoral Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma

This is a multi-center clinical study enrolling up to 86 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, as well as to assess the Duration of Response (DOR) 6 months from initial response. Secondary objectives are to assess the safety of DaRT, and to assess the progression free survival (PFS), overall survival (OS), Overall Duration of Response (O-DOR), local control and quality of life (QOL) for patients treated with DaRT.

Read the detailed description

This study is a prospective multicenter, pivotal, single arm, open label clinical study to assess the efficacy and safety of intratumoral Alpha DaRT-224 for the treatment of patients with recurrent cutaneous squamous cell carcinoma.

The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial 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. DaRT seeds will be inserted into recurrent Squamous Cell Carcinoma (SCC) tumors and will be removed following 14-21 days.

The Objective Response Rate (ORR) will be determined based on the confirmed Best Overall Response (BOR) following DaRT insertion. Duration of Response (DOR) will be assessed for up to 6 months from initial response is documented. 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.

Being tested
DaRT seeds
Keywords
Squamous Cell Carcinoma, Recurrent Squamous Cell Carcinoma, Alpha emitting radiation, Carcinoma, Squamous, Skin Cancer, Brachytherapy
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

    DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed.

Study groups in NCT05323253
Study groupRoleWhat they receive
DaRT seedsExperimentalDaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. Objective Response Rate (ORR) will be determined based on confirmed BOR following DaRT insertion.
Receives: Device: DaRT seeds

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Objective Response Rate (ORR) of DaRT as treatment for Recurrent SCC established by the confirmed Best Overall Response (BOR), with confirmation at least 4 weeks after initial assessment

    Measured: From Day 14 until 52 weeks

  2. Duration of Response

    Assess the Duration of Response (DOR) of DaRT as treatment for Recurrent SCC

    Measured: 6 months from from first demonstration of CR or PR after Alpha DaRT seeds insertion.

Secondary outcomes (7)

  1. Progression Free Survival

    Determine Progression Free Survival (PFS) of SCC following DaRT treatment

    Measured: Up to 12 months after DaRT seed insertion

  2. Overall Survival

    Assess Overall Survival (OS) of Recurrent SCC patients treated with DaRT

    Measured: Up to 12 months following DaRT insertion

  3. Time of Local Control

    Local control of SCC following DaRT treatment is measured as the time from first recorded response (Complete Response/Partial Response/Stable Disease) to local recurrence up to 12 months or last follow up

    Measured: Up to 12 months following DaRT insertion

  4. Patients Quality of Life Assessment

    Assess patient reported health related quality of life (QOL) outcomes using the Skin Cancer Index (SCI) and Skindex-16 questionnaires

    Measured: On 14 days,12 weeks and 52 weeks following DaRT insertion

  5. DaRT-related Adverse Events

    Assess the safety of the Alpha DaRT treatment, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE v5

    Measured: Up to 12 months following DaRT insertion

  6. Overall Duration of Response (O-DOR)

    O-DOR Defined as the time from first response (CR or PR) to the date of initial objectively documented progression or death due to any cause, whichever occurs first.

    Measured: Up to 12 months following first reported response

  7. User experience

    Assess user experience as determined by questionnaire

    Measured: On Day 0 (DaRT insertion) and Day 14 (+7) (DaRT removal)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start21 Sep 2022
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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, Pivotal, Single Arm, Open Label pivotal trial with DaRT for the treatment of Recurrent Cutaneous Squamous Cell Carcinoma
Masking
None (open label)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05323253
Sponsor's protocol ID
CTP-SCC-03
Status last verified
May 2026
First submitted
1 Apr 2022
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing DaRT seeds in people with Recurrent Squamous Cell Carcinoma, run by Alpha Tau Medical LTD. at 28 sites in 3 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 25 inclusion and 26 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 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 28 sites in United States, Israel, 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?

Objective Response Rate (time frame: From Day 14 until 52 weeks). 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?

On the ClinicalTrials.gov record for NCT05323253.

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.

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