A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma
NCT ID: NCT05323253
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
86 participants
INTERVENTIONAL
2022-09-21
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DaRT seeds
DaRT 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.
DaRT seeds
DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed.
Interventions
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DaRT seeds
DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Central histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment
3. Measurable disease according to RECIST v 1.1.
4. Ability to undergo a CT scan
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).
8. Interstitial implant indication validated by multidisciplinary team.
9. Eastern Cooperative Oncology Group (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 3 months 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:
* 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.
Exclusion Criteria
2. T4 disease or perineural spread of disease
3. Previously untreated cutaneous SCC indicated for surgery or radiation.
4. Mucosal, vulvar, anal and penile SCC.
5. Inability to fully cover the entire volume with DaRT seeds
6. Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs
7. Inability to undergo a CT scan
8. Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
9. Patients receiving any of the following within 4 weeks of enrollment:
1. Antineoplastic systemic chemotherapy or biological therapy
2. Immunotherapy
3. Investigational agents other than the study intervention
4. Radiation therapy
5. 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 3 months after the DaRT insertion visit.
20. Breastfeeding or pregnant women
21. Tattoos or other identifying marks which can not be adequately hidden on digital photos
18 Years
ALL
No
Sponsors
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Alpha Tau Medical LTD.
INDUSTRY
Responsible Party
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Locations
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Banner Health MD Anderson Phoenix
Gilbert, Arizona, United States
Dignity Health Cancer Institute
Phoenix, Arizona, United States
Alliance Dermatology
Phoenix, Arizona, United States
UCLA
Los Angeles, California, United States
Day Star Skin and Cancer Center
DeLand, Florida, United States
Integrity Research Clinical Associates
Delray Beach, Florida, United States
Palm beach Dermatology Group
Delray Beach, Florida, United States
Hollywood Dermatology
Hollywood, Florida, United States
University of Miami
Miami, Florida, United States
Baptist Health South Florida MCI
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Beer Dermatology
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Schweiger Dermatology Group
Hackensack, New Jersey, United States
New Mexico Cancer Center
Albuquerque, New Mexico, United States
Bassett Healthcare Network
Cooperstown, New York, United States
Northwell Health
Queens, New York, United States
New York Medical Skin Solutions
Rockaway Park, New York, United States
MDCS Dermatology
Smithtown, New York, United States
West Cancer Center
Germantown, Tennessee, United States
Gulf Coast Cancer Center
Houston, Texas, United States
University Cancer & Diagnostic Center
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Dermatology of Seattle and Bellevue
Bellevue, Washington, United States
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Rambam Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Belinson-Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTP-SCC-03
Identifier Type: -
Identifier Source: org_study_id
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