Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)
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|ClinicalTrials.gov Identifier: NCT03886181|
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : June 15, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Skin Cancer Mucosal Neoplasm of Oral Cavity Soft Tissue Neoplasm||Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)||Not Applicable|
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 volume and evaluation the percent of necrotic tissue in the tumor 30-45 days after DaRT seeds insertion (15-30 days after seed removal) will be assessed. Safety will be assessed by the cumulative incidence, worst severity and frequency of adverse events (AEs) observed including the follow-up period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety and Preliminary Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia|
|Actual Study Start Date :||July 8, 2021|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Device: 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.
- Evaluate the safety of the DaRT treatment [ Time Frame: 5-7 weeks after DaRT seed insertion. ]The study primary objective is to evaluate the safety of the DaRT treatment in terms of incidence of device related Serious Adverse Events (SAE).
- Evaluation the effectiveness of the treatment. [ Time Frame: Tumor volume will be measured during screening, 5 and 30-45 days post DaRT after treatment using CT. ]Evaluation on the effectiveness of the DaRT treatment, in terms of tumor volume reduction.
- Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic [ Time Frame: 15-30 days after removal of DaRT seeds. ]Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic tissue present in the remaining tumor tissue surgically removed 15-30 days after removal of DaRT seeds.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects with histopathological confirmation of cutaneous and/or mucosal and/or superficial soft tissue malignant neoplasia.
- Subjects with a tumor size ≤ 5 centimeters in the longest diameter.
- Subjects' age is over 18 years old.
- Subjects' ECOG Performance Status Scale is < 2.
- Subjects' life expectancy is more than 6 months.
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
- Subjects are able and willing to sign an informed consent form.
- Subject has a tumor with a maximal diameter > 5 centimeters.
- Subjects' ECOG Performance Status Scale is > 3.
- Subject has a tumor of Keratoacanthoma histology.
- Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc.
- Patients under systemic immunosuppressive and/or corticosteroid treatment. Patients taking corticosteroid inhalers are eligible.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886181
|Contact: Liron Dimnik||+972-2-373-7000||LironD@alphatau.com|
|IRCCS Istituto Dermatologico S. Gallicano, IFO - Istituti Fisioterapici Ospitalieri - Dermatologia Oncologica e Prevenzione||Recruiting|
|Rome, Lazio, Italy|
|Contact: Laura Eibenschuz, MD|
|Principal Investigator: Laura Eibenschuz, MD|
|Principal Investigator:||Laura Eibenschuz, MD||IFO S. Gallicano|
|Responsible Party:||Alpha Tau Medical LTD.|
|Other Study ID Numbers:||
|First Posted:||March 22, 2019 Key Record Dates|
|Last Update Posted:||June 15, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Squamous Cell Carcinoma
Basal cell carcinoma
Soft Tissue Neoplasms
Neoplasms by Site
Head and Neck Neoplasms