Status:
UNKNOWN
In-hospital Neutron Irradiator (IHNI)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment of Malignant Melanoma
Lead Sponsor:
The Third Xiangya Hospital of Central South University
Collaborating Sponsors:
Beijing Capture Technology Co., Ltd
Conditions:
Melanoma
Boron Neutron Capture Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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. Theoreti...
Detailed Description
This is a single BNCT-facility, non-randomized, non-comparative, open-label, phase I to II clinical trial to determine the value of IHNI in the performance of BNCT. Before patients are recruited in th...
Eligibility Criteria
Inclusion
- Sign an informed consent form.
- Age above 18, gender unlimited.
- Expectation of life above 3 months.
- 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.
- KPS score: ≥70%.
- Eastern Cooperative Oncology Group (ECOG) score: 0-2 grade.
- (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.
- Never accepted radiation or chemotherapy, or the interval of radiation or chemotherapy administered above 3 month.
- Never accepted target drugs or biotherapeutics.
- Urine pregnancy test negative (selectivity).
Exclusion
- Intolerable to BNCT treatment.
- Sever coagulation disorders.
- Poor compliance.
- Sever complications or infection without control.
- Pregnant woman or woman in lactation period.
- Patients with metallic instruments (such as pacemaker, artificial limb).
- Boron concentration in tumor tissue was \<1.5 times that in blood.
- Age\<18.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02759536
Start Date
July 1 2013
Last Update
June 7 2016
Active Locations (1)
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1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013