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RECRUITING NA

A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma

NCT05323253 · View on ClinicalTrials.gov ↗

Study 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 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.

Interventions

  • DEVICE DaRT seeds

Study Locations (20)

Florida

  • Day Star Skin and Cancer Center — DeLand
  • Integrity Research Clinical Associates — Delray Beach
  • Palm beach Dermatology Group — Delray Beach
  • Hollywood Dermatology — Hollywood
  • University of Miami — Miami
  • Baptist Health South Florida MCI — Miami
  • Moffitt Cancer Center — Tampa
  • Beer Dermatology — West Palm Beach

New York

  • Bassett Healthcare Network — Cooperstown
  • Northwell Health — Queens
  • New York Medical Skin Solutions — Rockaway Park
  • MDCS Dermatology — Smithtown

Arizona

  • Banner Health MD Anderson Phoenix — Gilbert
  • Dignity Health Cancer Institute — Phoenix
  • Alliance Dermatology — Phoenix

California

  • UCLA — Los Angeles

Georgia

  • Emory University — Atlanta

Minnesota

  • Mayo Clinic Rochester — Rochester

New Jersey

  • Schweiger Dermatology Group — Hackensack

New Mexico

  • New Mexico Cancer Center — Albuquerque

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2022-09-21
Est. Completion 2025-12
Phase NA

Sponsor

Alpha Tau Medical

62 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05323253

The ClinicalTrials.gov registry entry for NCT05323253 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alpha Tau Medical, which has 62 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Recurrent Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention — of which DaRT seeds is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05323253 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, New York, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05323253 about?

NCT05323253 is a clinical study titled "A Clinical Study to Assess the Efficacy and Safety of 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 wel...

What is the current status of trial NCT05323253?

This trial is currently recruiting. It is a NA study. The enrollment target is 86 participants. The study started on 2022-09-21. Estimated completion is 2025-12.

What conditions does trial NCT05323253 study?

This clinical trial studies the following conditions: Recurrent Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05323253?

The interventions under investigation include: DaRT seeds (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05323253?

This trial is sponsored by Alpha Tau Medical, which has 62 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05323253 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial