Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Recurrence

Carcinoma

Skin Neoplasms

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. Objective Response Rate (ORR) will be determined based on confirmed BOR following DaRT insertion.

DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed.

DaRT seeds

Liron Dimnik

Aviya Hoida

Michael Samuels, MD

Pamela Urban

Shyamal Patel, MD

Rebecca Pena

Albert Chang, MD

Jackie Hernandez

Yi Jen Chen, MD

Hesham Mahmoud

Michael E Kasper, MD

Ileana Vargas

Matthew Abramowitz, MD

Zuzel Rodrigues

Noah S Kalman, MD

Evan Wuthrick, MD

Zachary Buchwald, MD

Stacie Hitchcook

Arshin Sheybani, MD

Sheila Young

Mauricio Gamez, MD

Benjamin Rosenbluth, MD

Lydia M Ko

Gregg E.Franklin, MD

Sarah Tellez

Timothy Korytko, MD

Katelyn Tessier

Bhupesh Parashar, MD

Christipher Barker, MD

Ming Lian

Joshua Palmer, MD

Sujith Baliga

Noam Vanderwalde, MD

Catherine Morningstar

Mark D'Andrea, MD

Jo Ann Ramirez

Christopher McLaughlin, MD

Song Wood

Elie Levy, MD

Tomer Charas, MD

Aron Popovtzer, MD

Elisha Fredman, MD

Iris Gluck, MD

Shlomit Shamir Druskin

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.

This study is a prospective multicenter, pivotal, single arm, open label clinical study to assess the efficacy and safety of intratumoral Alpha DaRT-224 for the treatment of patients with recurrent cutaneous squamous cell carcinoma.

The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. DaRT seeds will be inserted into recurrent Squamous Cell Carcinoma (SCC) tumors and will be removed following 14-21 days.

The Objective Response Rate (ORR) will be determined based on the confirmed Best Overall Response (BOR) following DaRT insertion. Duration of Response (DOR) will be assessed for up to 6 months from initial response is documented. Safety will be assessed based on the cumulative incidence rate, severity and outcome of device related Adverse Events (AEs). Classification of AEs will be done according to CTCAE v5.

This is an International Multicenter, Pivotal, Single Arm, Open Label pivotal trial with DaRT for the treatment of Recurrent Cutaneous Squamous Cell Carcinoma

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

A Prospective International Multicenter, Pivotal, Single Arm, Open Label Clinical Study to Assess the Efficacy and Safety of Intratumoral Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma

Objective Response Rate (ORR) of DaRT as treatment for Recurrent SCC established by the confirmed Best Overall Response (BOR), with confirmation at least 4 weeks after initial assessment

Assess the Duration of Response (DOR) of DaRT as treatment for Recurrent SCC

Determine Progression Free Survival (PFS) of SCC following DaRT treatment

Assess Overall Survival (OS) of Recurrent SCC patients treated with DaRT

Local control of SCC following DaRT treatment is measured as the time from first recorded response (Complete Response/Partial Response/Stable Disease) to local recurrence up to 12 months or last follow up

Assess patient reported health related quality of life (QOL) outcomes using the Skin Cancer Index (SCI) and Skindex-16 questionnaires

Assess the safety of the Alpha DaRT treatment, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE v5

O-DOR Defined as the time from first response (CR or PR) to the date of initial objectively documented progression or death due to any cause, whichever occurs first.

Assess user experience as determined by questionnaire

Alpha Tau Medical LTD.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Vulvar Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Vulvar Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vulvar Cancer

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

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

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva.

This is an prospective Open label, single arm, multi center, interventional study treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva .The study objectives are to collect data on the Feasibility and Safety of DaRT among patients who do not fit the entry of existing investigational trials.

The primary endpoint of the study is to evaluate the feasibility and safety of the Alpha DaRT sources for the treatment of vulva SCC. Feasibility will be determined according to the rate of successful placement of Alpha DaRT . Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria.

The Secondary endpoint of the study will be to evaluate efficacy, as determined by local control evaluation according to RECIST v1.1

Alpha Radiation Emitters Device for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva (DaRT).

A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva

Feasibility will be determined according to the rate of successful placement of Alpha DaRT

Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria.

The study's secondary objective will be to evaluate efficacy, as determined by local control evaluation according to RECIST v1.1

DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. The study objectives are to collect data on the general safety and efficacy of DaRT among patients who do not fit the entry criteria of existing investigational trials.

Experimental: DaRT seeds

Aron Popovzer, MD

Hanna Lea Knafou

This study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events 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. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.

This is an Open label, one arm, prospective study for Compassionate use for the treatment of malignant tumors. The study objectives are to collect data on the safety and efficacy of DaRT among patients who do not fit the entry of existing investigational trials.

The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events 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. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.

A Study of Diffusing Alpha Radiation Therapy for Target Treatments of Malignant Tumors

A Prospective, Open Label, One Arm Study for a Compassionate Use of Diffusing Alpha Radiation Therapy

The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events 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.

The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

Digestive System Diseases

Neoplasm Metastasis

Liver Neoplasms

Neoplastic Processes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Alpha DaRT Applicators (the Alpha Needle Applicator, the Alpha Flex Applicator, and the Alpha Plant Applicator) and radioactive sources named Alpha DaRT Seeds - Ra-224 coated onto stainless steel tubes inserted into the tumor. Collectively, the Alpha DaRT Applicators and Seeds are referred to as the "Alpha DaRT Device".

Diffusing Alpha Radiation Emitters Therapy (DaRT)

Peter Metrakos, MD

Anthoula Lazaris

This is a single center study enrolling up to 10 patients. The primary objective is to Evaluate the feasibility and safety of the DaRT for the treatment of Liver Metastases. The secondary objective is to evaluate the pathological response of liver metastases according to the Modified tumor regression grade\[1\] and to evaluate the radiological response of liver metastases using the RECIST criteria.

This study is a Prospective, Open label, one arm, single center study to evaluate the feasibility and safety of Diffusing Alpha Radiation Emitters for the treatment of Liver Metastases .

Alpha Tau Medical proposes a unique treatment methodology for patients with liver metastases - Diffusing Alpha-emitters Radiation Therapy (DaRT) - whereby alpha particles are used to destroy solid tumors. The concept is predicated on the use of DaRT radioactive sources for radiotherapy.

DaRT is based on a nuclear decay chain originating with thorium-228 (1.91 years half-life). Outside of negligible, non-significant trace amounts, the thorium-228 remains confined to the Alpha Tau Medical manufacturing facility, and is used to generate radium-224, which is coated onto 316LVM stainless steel wires (Alpha DaRT Seeds).

The Primary endpoint of the study is : 1) Feasibility assessments of the ability to achieve full volume coverage of liver metastases volume.

2) Safety of the Alpha DaRT Seeds as therapy for liver metastases , Safety will be assessed and recorded according to CTCAE V5.

Alpha Radiation Emitters Device for the Treatment of Liver Metastases (DaRT)

A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Liver Metastases

Assessment of successful placement of the Alpha DaRT Seeds into liver metastases during a 2-stage hepatectomy via imaging

Assess the frequency and severity of acute adverse events related to DaRT. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0.

Pathological response to Alpha DaRT Seeds in covered areas after surgery

Radiological response to Alpha DaRT seeds implantation after the Alpha DaRT Seeds insertion procedure and prior to the second stage

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed Devices

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.

Noga Kurman, MD

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device.

This will be a prospective, first in man, 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.

Lesions with histopathological diagnosis of squamous cell carcinoma will be studied.

Reduction in tumor size 30 days after DaRT insertion will be assessed.

Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma (First in Man)

The incidence, severity and frequency of all Adverse Events

The reduction in tumor size 30-45 days after DaRT insertion

Percent of necrotic tissue in the tumor 30 days after DaRT insertion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma	NCT05323253	Recurrent Squam...	DaRT seeds	18 Years -	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva (DaRT).	NCT06202339	Carcinoma of th... Recurrent Carci...	DaRT seeds	18 Years - 120 Years	Alpha Tau Medical LTD.
A Study of Diffusing Alpha Radiation Therapy for Target Treatments of Malignant Tumors	NCT05781555	Malignant Tumor	Experimental: D...	18 Years -	Alpha Tau Medical LTD.
A Study of Diffusing Alpha Radiation Therapy for Target Treatments of Malignant Tumors	NCT05781555	Malignant Tumor	Experimental: D...	18 Years -	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device for the Treatment of Liver Metastases (DaRT)	NCT05829291	Liver Metastase...	Diffusing Alpha...	18 Years -	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma	NCT03015883	Squamous Cell C...	Diffusing Alpha...	18 Years -	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva (DaRT).	NCT06202339	Carcinoma of th... Recurrent Carci...	DaRT seeds	18 Years - 120 Years	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva (DaRT).	NCT06202339	Carcinoma of th... Recurrent Carci...	DaRT seeds	18 Years - 120 Years	Alpha Tau Medical LTD.

Spots Global Cancer Trial Database for alpha emitting radiation