Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia

Skin Cancer Clinical Trial

Official title:

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04534127
• Other study ID #: CTP-CMN-02_
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2020
• Est. completion date: January 1, 2026

Study information

• Verified date: July 2023
• Source: Alpha Tau Medical LTD.
• Contact: Liron Dimnik
• Phone: +972-2-373-7000
• Email: LironD[@]alphatau.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

Description:

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. Confirmation obtained within 6 months of planned treatment.

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

• Targetable lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds

• Brachytherapy indication validated by a multidisciplinary team

• Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.

• 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.

• WBC = 3500/µl, granulocyte = 1500/µl

• AST and ALT = 2.5 X ULN

• International normalized ratio of prothrombin time =1.8.

• Creatinine =1.9 mg/dL. Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.

• Subjects are willing to sign an informed consent form.

Exclusion Criteria:

• Subject has a tumor of Keratoacanthoma histology.

• Known hypersensitivity to any of the components of the treatment.

• Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.

• Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.

• Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids

• Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT

• 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.

• Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.

• High probability of protocol non-compliance (in opinion of investigator).

• Subjects not willing to sign an informed consent.

• Women who are pregnant or breastfeeding.

Related Conditions & MeSH terms

• Mouth Neoplasms
• Mucosal Neoplasm of Oral Cavity
• Neoplasms
• Skin Cancer
• Skin Neoplasms
• Soft Tissue Neoplasm
• Soft Tissue Neoplasms

Intervention

Device:
• Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.

Locations

Country	Name	City	State
Israel	Sharett institute, Hadassah Medical Center - Ein-Kerem	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Alpha Tau Medical LTD.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	All Adverse Events (AE) related and unrelated to the study treatment	Up to 24 Months
Primary	Tumor response to DaRT	Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)	9-11 weeks post DaRT insertion
Primary	Adverse Events	The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.	Up to 24 Months
Secondary	Change in tumor volume	Based on imaging	9-11 weeks post DaRT insertion
Secondary	DaRT seeds placement	Assessment by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion	1 Day of procedure
Secondary	Change in quality of life	Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score	Day 15, Day 30, Day 70, Day 180 post DaRT insertion
Secondary	Change in quality of life	Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score	Day 30, Day 70, Day 180 post DaRT insertion
Secondary	Progression Free Survival	Time elapsed from response to disease progression	24 months post DaRT insertion