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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.

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Liron Dimnik

Aron Popovtzer, MD

Aron Popovtzer

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

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).

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

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

All Adverse Events (AE) related and unrelated to the study treatment

Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

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.

Assessment by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion

Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score

Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score

Time elapsed from response to disease progression

Alpha Tau Medical LTD.

Recurrence

Adi Cohen

Naama Barel

Aron Popovtzer, M.D

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of re-treatment with 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 either recurrent or persistent disease following DaRT treatment. .

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).

Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

A Safety and Efficacy Study of Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

Incidence of all Adverse Events (AE) related and unrelated to the study treatment.

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.

Will be assessed as the number of complete responses, partial responses and stable disease divided by the total numbers of tumors treated.

Tomer Charas, MD

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

Assessment of the rate of malignant cutaneous, mucosal or superficial soft tissue tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment

Assessment of the reduction in tumor volume based on CT / PET-CT measured tumor volume

Assessment of the DaRT seeds placement by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion.

Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score. An overall score ranging from 0 (best) to 100 (worst).

Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score. An overall score ranging from 0 (best) to 100 (worst).

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Laura Eibenschuz, MD

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.

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

A Safety and Preliminary Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia

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.

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 on the effectiveness of the DaRT treatment, in terms of tumor volume reduction.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia	NCT04534127	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Radiation: Diff...	18 Years -	Alpha Tau Medical LTD.
Retreatment With Intratumoral Diffusing Alpha Radiation Emitters	NCT04540588	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Radiation: Diff...	18 Years -	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.	NCT03889899	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Radiation: Diff...	18 Years -	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)	NCT03886181	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Device: Radiati...	18 Years -	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)	NCT03886181	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Device: Radiati...	18 Years -	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)	NCT03737734	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Radiation: Diff...	18 Years -	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.	NCT03889899	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Radiation: Diff...	18 Years -	Alpha Tau Medical LTD.

Spots Global Cancer Trial Database for mucosal neoplasm of oral cavity