An interventional study of Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in Breast Carcinoma, Metastatic Breast Cancer and Invasive Breast Cancer, sponsored by Alpha Tau Medical LTD.. Terminated at 1 site in Russian Federation. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Alpha Tau Medical LTD. · Not applicable, Interventional, and Treatment
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for newly Diagnosed Breast Carcinoma patients with distant metastases
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 sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)] inserted into malignant breast lesions.
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.
Histopathological confirmed invasive breast tumors with no involvement of skin will be treated using DaRT seeds.
The primary effectiveness endpoint of the study is the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 9-11 weeks after DaRT seed insertion.
Safety will be assessed by the cumulative frequency, severity and causality of acute adverse events related to the DaRT treatment of adverse events (AEs) observed including the follow-up period.
6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.
This study's enrollment of 1 is below the median of 45 across 5,167 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Alpha Tau Medical LTD. is the lead sponsor of 28 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
An intratumoral insertion of radioactive sources \[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
Tumor response to DaRT
Assessment of the rate of malignant breast tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
Time frame: 9-11 weeks post DaRT insertion.
Adverse Events
Assessment of the frequency, severity and causality of acute adverse events related to the DaRT treatment using the Common Terminology and Criteria for adverse events (CTCAE) version 5.0
Time frame: Day 0 - 6 months (+/-14 days)
Change in tumor volume.
Assessment of the reduction in tumor volume SUVmax based on CT/PET - CT measured tumor volume.
Time frame: 9-11 weeks after DaRT insertion.
DaRT seeds placement
Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging.
Time frame: Day of insertion.
Change in quality of life: EORTC-QLQ-C30
Assessment of patient reported health-related Quality of Life (QoL) outcomes after DaRT treatment, using QoL questionnaires EORTC-QLQ-C30. Scale range in score from 0 (best) to 100(worst).
Time frame: Day 0, 30, 70, 6 months (+/-14 days).
Progression free survival
Time elapsed from response to disease progression.
Time frame: 6 months (+/-14 days).
Pathological remissions.
Assessment of (complete) pathological remissions using histopathology examination
Time frame: 12 weeks after DaRT seed insertion.
Abscopal effects.
Assessment of abscopal effects on existing distant metastases based on PET-CT measured tumor volume.
Time frame: 9-11 weeks after DaRT insertion.
Change in quality of life: BR23
Assessment of patient reported health-related Quality of Life (QoL) outcomes after DaRT treatment, using QoL questionnaires BR23. Scale range in score from 0 (best) to 100(worst).
Time frame: Day 0, 30, 70, 6 months (+/-14 days).
Abscopal effects
Assessment of abscopal effects on existing distant metastases based on PET-CT measured SUVmax decrease compared to the primary measurement (the baseline measurement).
Time frame: 9-11 weeks after DaRT insertion.
Plan to share: No
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This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Alpha Tau Medical LTD.