A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:

‣ SCC

⁃ BCC

⁃ Lentigo maligna melanoma (Dubreuilh melanoma)

⁃ Carcinosarcoma

• Acceptable tumor locations include the following:

‣ Skin (facial, scalp, extremities, torso)

⁃ Lips

⁃ Eyelids

• Subjects with a tumor size ≤ 7 centimeters in the longest diameter.

• Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.

• Measurable disease according to RECIST v1.1.

• Subjects over 18 years old.

• Subjects' ECOG Performance Status Scale is \< 2.

• Subjects' life expectancy is more than 6 months.

• Platelet count ≥100,000/mm3.

• International normalized ratio of prothrombin time ≤1.8.

• Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.

• Subjects are willing to sign an informed consent form

Locations
Other Locations
France
CHU Grenoble Alpes
RECRUITING
Grenoble
Centre Léon Bérard
RECRUITING
Lyon
Contact Information
Primary
Liron Dimnik
LironD@alphatau.com
+972-2-373-7000
Backup
Amnon Gat
Amnong@alphatau.com
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2025-01
Participants
Target number of participants: 80
Treatments
Experimental: DaRT Seeds Intratumoral Diffusing alpha-emitters
An intratumoral insertion of securely fixed seeds loaded with Radium-224. The seeds release by recoil short-lived alpha-emitting atoms into the tumor.
Related Therapeutic Areas
Sponsors
Leads: Alpha Tau Medical LTD.

This content was sourced from clinicaltrials.gov