An interventional study of HB-001 in Breast Cancer and Head and Neck Cancer, sponsored by Hekabio. Completed at 4 sites in Japan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by Hekabio · Not applicable, Interventional, and Treatment
An intratumoral alpha particle based approach for cancer treatment using diffusion alpha-emitting radiation therapy (DaRT)
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).
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 14 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
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Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Device: HB-001
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.
Also known as: DaRT(Diffusing Alpha Radiation Emitters Therapy)
Tumor response to HB-001
Assessment of tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Time frame: 9 - 11 weeks after HB-001 seed insertion
Adverse Events
The incidence, frequency, severity and causality of adverse events related to the HB-001
Time frame: 12 weeks after HB-001 insertion
Plan to share: No
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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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