Clinical trial · Interventional
Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan
Study of the Safety and Efficacy of Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan
NCT04906070CI-TRIAL-00058885completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An intratumoral alpha particle based approach for cancer treatment using diffusion alpha-emitting radiation therapy (DaRT)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HB-001 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HB-001 DaRT Seeds
- description
- Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
- interventionNames
- Device: HB-001
Primary outcomes (1)
- measure
- Tumor response to HB-001
- timeFrame
- 9 - 11 weeks after HB-001 seed insertion
- description
- Assessment of tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Secondary outcomes (1)
- measure
- Adverse Events
- timeFrame
- 12 weeks after HB-001 insertion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Head and neck cancer or breast cancer patients with histopathological proven malignancies who have a history of radiation therapy and who have been diagnosed with refractory malignancies with or without medical treatment. 2. Tumor size is 5 cm or less in the longest diameter 3. Age 18 years or older 4. Eastern Cooperative Oncology Group performance status is 2 or less 5. Life expectancy: 6 months or longer 6. Vital signs (systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate) are stable 7. Platelet count \>= 100,000/mm3 and prothrombin time Prothrombin Time-International Normalized Ratio \<= 1.8 8. Women of childbearing potential have to be confirmed not pregnant by a pregnancy test and have to agree to prevent conception throughout the study. 9. Having received explanation about the study, consented to participate in the study and signed the informed consent form. 10. Measurable disease according to RECIST v1.1 Exclusion Criteria: 1. The size of the tumor more than 5 cm in the maximum diameter. 2. ECOG performance status is 3 or higher 3. Continuously receiving medication that may have a significant impact on the evaluation of safety or efficacy, such as immunosuppressants and/or corticosteroids. 4. History of serious allergy to the medicine for the treatments like anesthesia. 5. There are tumors to be preferentially treated such as metastatic lesion other than the target tumor 6. Having received chemotherapeutic drugs (except hormonal agents), immunotherapeutic agents, and molecular targeting agents in the past 30 days, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy. 7. Having received immune checkpoint inhibitor in the past 2 months, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy. 8. Having participated in different clinical studies in the past 30 days, which may affect the assessment of the safety or efficacy of HB-001 brachytherapy 9. Pregnant women or breast-feeding mothers 10. Those who do not wish to sign the informed consent form
References
Publications (0)
Data not yet available
No reference posted for this study.