In-hospital Neutron Irradiator (IHNI)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment of Malignant Melanoma
1 other identifier
interventional
30
1 country
1
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 18, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedJune 7, 2016
April 1, 2016
5.4 years
April 18, 2016
June 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants showing CR/PR to IHNI-based BNCT
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.
baseline and 2 years
Secondary Outcomes (1)
Percentage of participants with treatment-related adverse events
1 week, 1 month, 3 months, 6 months, 1 year and 2 years
Other Outcomes (1)
Percentage of participants of improved life quality.
baseline and 1 year
Study Arms (1)
Boronophenylalanine and IHNI-based BNCT
EXPERIMENTALInterventions
Patients will be infused Boronophenylalanine (BPA)-fructose solution intravenously at a dose of 350mg/kg over 90 minutes. After BPA infusion, patients will receive neutron irradiation in IHNI for a certain period of time based on his boron bio-distribution curve and BPA concentration in the blood.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Related Publications (1)
Ke 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: 19427794BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shaihong Zhu, M.D.
The Third Xiangya Hospital of Central South University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2016
First Posted
May 3, 2016
Study Start
July 1, 2013
Primary Completion
December 1, 2018
Last Updated
June 7, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will share