Clinical trial · Interventional
In-hospital Neutron Irradiator (IHNI)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment of Malignant Melanoma
In-hospital Neutron Irradiator (IHNI)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment of Malignant Melanoma: A Feasibility Study
- 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)
Boron Neutron Capture Therapy (BNCT) has been used in the treatment of several types of malignant tumors, including malignant melanoma, high-grade gliomas, and advanced head and neck cancers. Theoretically, it represents a more precise radiotherapy in that it could spare normal cells while destroy malignant ones. However, its value is largely restricted by the fact that it could only be performed in the nuclear research reactors, the only neutron source at the time. In 2010, the world's first in-hospital neutron irradiator (IHNI) had been constructed in Beijing, China, and this study aims to evaluate whether IHNI has the potential to serve as an effective in-hospital neutron source for BNCT.
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 |
|---|---|---|---|
| Boron Neutron Capture Therapy | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Boronophenylalanine and IHNI-based BNCT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Boronophenylalanine and IHNI-based BNCT
- interventionNames
- Radiation: Boronophenylalanine and IHNI-based BNCT
Primary outcomes (1)
- measure
- Percentage of participants showing CR/PR to IHNI-based BNCT
- timeFrame
- baseline and 2 years
- description
- CT scan will be performed on each patient before and 2 years after irradiation, up to a maximum of 2 lesions of the longest diameter (unit: millimeter, mm) will be selected as target lesion(s). The diameter of the targeted lesion(s) will be measured on CT images. The change in the diameter of the targeted lesion(s) will be used to evaluate the patient's treatment response to IHNI-based BNCT according to Response Evaluation Criteria in Solid Tumors (RECIST). RECIST consists of four types of response: complete response (CR), partial response (PR), Stable Disease (SD), and Progressive Disease (PD). The percentage of participants who show CR/PR will be used to evaluate the efficiency of IHNI-based BNCT.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Sign an informed consent form. 2. Age above 18, gender unlimited. 3. Expectation of life above 3 months. 4. Characteristic of disease: ① Pathological analysis confirms the diagnosis of melanoma. ② PET-CT and serum lactate dehydrogenase (LDH) can be used for auxiliary diagnosis. ③Diameter of at least one solid tumor ≥ 1cm. 5. KPS score: ≥70%. 6. Eastern Cooperative Oncology Group (ECOG) score: 0-2 grade. 7. (Within a week) Complete blood count: hemoglobin≥90g/L, leukocyte ≥ 4.0×109/L, neutrophilic granulocyte ≥ 2.0×109/L, platelet ≥ 100.0×109/L; Renal function: creatinine ≤ 180 umol/L. 8. Never accepted radiation or chemotherapy, or the interval of radiation or chemotherapy administered above 3 month. 9. Never accepted target drugs or biotherapeutics. 10. Urine pregnancy test negative (selectivity). Exclusion Criteria: 1. Intolerable to BNCT treatment. 2. Sever coagulation disorders. 3. Poor compliance. 4. Sever complications or infection without control. 5. Pregnant woman or woman in lactation period. 6. Patients with metallic instruments (such as pacemaker, artificial limb). 7. Boron concentration in tumor tissue was \<1.5 times that in blood. 8. Age\<18.
References
Publications (1)
- BACKGROUNDKe G, Sun Z, Shen F, Liu T, Li Y, Zhou Y. The study of physics and thermal characteristics for in-hospital neutron irradiator (IHNI). Appl Radiat Isot. 2009 Jul;67(7-8 Suppl):S234-7. doi: 10.1016/j.apradiso.2009.03.117. Epub 2009 Apr 9. PMID 19427794