Actively Recruiting
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
Led by Alpha Tau Medical LTD. · Updated on 2025-12-02
86
Participants Needed
30
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Alpha DaRT-224, a treatment involving the placement of radioactive seeds directly into tumors, for patients with recurrent cutaneous squamous cell carcinoma who have not responded to standard treatments. This prospective, multicenter, single-arm study aims to measure how well tumors respond to this therapy, the duration of response, progression-free survival, overall survival, local tumor control, and patient quality of life. The treatment involves inserting Alpha DaRT-224 seeds into the tumor using planned radiotherapy techniques. These radioactive seeds release alpha particles that target the tumor over a period of 14 to 21 days before being removed. Researchers use imaging to assess tumor response 2 to 3 weeks after placement. The study is open-label and does not include a comparison group. Participants will undergo regular assessments including imaging scans, blood tests, and quality of life questionnaires at specified intervals up to 12 months after treatment. Safety is closely monitored through reported adverse events related to the device. The main outcomes measured are tumor response and how long it lasts, with follow-up to document progression and survival. The total participation time varies with assessments scheduled from insertion through one year post-treatment.
CONDITIONS
Brief Title
A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with recurrent cutaneous squamous cell carcinoma confirmed by pathology who failed at least first line standard therapy and are not candidates for surgery or standard radiation
- Central histopathological confirmation within 6 months before enrollment without treatment between biopsy and enrollment
- Measurable tumor per RECIST v 1.1 criteria
- Ability to undergo a CT scan
- Tumor size 7 cm or smaller at longest diameter
- Only one lesion per patient
- Target lesion must be technically suitable for full coverage by DaRT seeds without obstruction by bone, major vessels, or vital organs
- Multidisciplinary team confirms suitability for interstitial implant
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Life expectancy of 12 months or more
- Male or female aged 18 years or older
- Ability and willingness to provide signed informed consent
- Patients with reproductive potential agree to use effective birth control during and for 3 months after treatment
- Women with childbearing potential have a negative pregnancy test prior to treatment
- Blood tests within specified ranges for white blood cells, neutrophils, platelets, liver enzymes, creatinine, and coagulation parameters
You will not qualify if you...
- Presence of distant or lymph node metastatic disease (N+ or M1)
- Tumor classified as T4 or showing perineural spread
- Untreated cutaneous squamous cell carcinoma suitable for surgery or radiation
- Mucosal, vulvar, anal, or penile squamous cell carcinoma
- Inability to achieve full coverage of tumor volume with DaRT seeds
- Inability to place DaRT seeds due to tumor location or obstruction
- Inability to undergo CT scan
- Current systemic immunosuppressive therapy except brief corticosteroids
- Receipt of chemotherapy, immunotherapy, investigational agents, radiation therapy, or live vaccines within specified timeframes before enrollment
- Tumor larger than 7 cm in longest diameter
- Tumor with keratoacanthoma histology
- Known allergy to any treatment components
- Significant cardiovascular disease or recent heart attack
- Medical or psychiatric conditions that may interfere with treatment or study participation
- Serious comorbidities affecting compliance or safety assessment
- Likely protocol non-compliance
- Participation in conflicting interventional studies within past 30 days
- Active additional malignancies requiring treatment, excluding certain skin or cervical cancers
- Refusal or inability to use adequate contraception
- Pregnancy or breastfeeding
- Tattoos or marks preventing adequate digital photography documentation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 to 21 days
Participants have DaRT seeds inserted into their tumor using preplanned radiotherapy parameters and undergo volumetric imaging to reassess the tumor.
1 visit for DaRT seed insertion and 1 visit for seed removal 14 to 21 days later
Duration - Up to 12 months
Participants are assessed for tumor response, adverse events, quality of life, and survival outcomes following DaRT seed removal.
Visits on Day 14, Week 12, and Week 52 post DaRT insertion, plus additional assessments as needed
Trial Site Locations
Total: 30 locations
1
Banner Health MD Anderson Phoenix
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
Dignity Health Cancer Institute
Phoenix, Arizona, United States, 85004
Completed
3
Alliance Dermatology
Phoenix, Arizona, United States, 85032
Actively Recruiting
4
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
5
Day Star Skin and Cancer Center
DeLand, Florida, United States, 32720
Actively Recruiting
6
Integrity Research Clinical Associates
Delray Beach, Florida, United States, 33445
Actively Recruiting
7
Palm beach Dermatology Group
Delray Beach, Florida, United States, 33484
Actively Recruiting
8
Hollywood Dermatology
Hollywood, Florida, United States, 33021
Actively Recruiting
9
University of Miami
Miami, Florida, United States, 33101
Actively Recruiting
10
Baptist Health South Florida MCI
Miami, Florida, United States, 33176
Actively Recruiting
11
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Completed
12
Beer Dermatology
West Palm Beach, Florida, United States, 33401
Actively Recruiting
13
Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
14
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
15
Schweiger Dermatology Group
Hackensack, New Jersey, United States, 07601
Actively Recruiting
16
New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
17
Bassett Healthcare Network
Cooperstown, New York, United States, 13326
Actively Recruiting
18
Northwell Health
Queens, New York, United States, 11375
Suspended
19
New York Medical Skin Solutions
Rockaway Park, New York, United States, 11694
Actively Recruiting
20
MDCS Dermatology
Smithtown, New York, United States, 11787
Actively Recruiting
21
West Cancer Center
Germantown, Tennessee, United States, 38138
Withdrawn
22
Gulf Coast Cancer Center
Houston, Texas, United States, 77008
Actively Recruiting
23
University Cancer & Diagnostic Center
Houston, Texas, United States, 77089
Actively Recruiting
24
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Withdrawn
25
Dermatology of Seattle and Bellevue
Bellevue, Washington, United States, 98004
Actively Recruiting
26
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Actively Recruiting
27
Rambam Medical Center
Haifa, Israel
Actively Recruiting
28
Hadassah Medical Center
Jerusalem, Israel, 9777605
Actively Recruiting
29
Belinson-Rabin Medical Center
Petah Tikva, Israel
Actively Recruiting
30
Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
Research Team
L
Liron Dimnik
A
Aviya Hoida
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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