Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors

ConditionsSkin Cancer Cutaneous Tumor Cutaneous Metastasis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAlpha Tau Medical LTD.

About this trial

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

SCC

BCC

Lentigo maligna melanoma (Dubreuilh melanoma)

Carcinosarcoma

Disqualifiers

Keratoacanthoma

Merkel cell carcinoma

Sarcoma other than carcinosarcoma

Metastatic disease (according to the TNM staging system - M1 patients are excluded)

Trial design

Design model

Single group

Treatments tested in this trial

DaRT- Diffusing Alpha-emitters Radiation Therapy
Device
Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles

Treatment groups

80 Participants

are divided into 1 treatment group

Group A: DaRT Seeds Intratumoral Diffusing alpha-emittersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

The objective response rate to DaRT treatment

Assessment of tumor response rate using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

Time frame

up to 9-11 weeks

Secondary outcomes

Tumor volume

Assessment of the reduction in tumor volume based on imaging tests

Time frame

up to 9-11 weeks

DaRT seeds placement

Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging

Time frame

Day of DaRT insertion procedure

Change in quality of life as assessed by the Skindex-16 questionnaire

Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skindex-16 questionnaire

Time frame

up to 9-11 weeks

Disease-Free Survival (DFS) rate

Assessment of Disease-Free Survival

Time frame

up to 24 months

Other outcomes

Adverse Events

Assessment of the frequency, severity and causality of adverse events related and not related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.

Time frame

up to 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alpha Tau Medical LTD.

Lead sponsor

Source ClinicalTrials.gov

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