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BNCT for skin malignancies

BNCT phase I / II trial for skin malignancies - BNCT phase I / II trial for skin malignancies

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061180066
Enrollment
10
Registered
2019-03-19
Start date
2017-11-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or recurrent skin malignancies Skin malignancies, BNCT

Interventions

1) Intravenous administration of BPA-fructose complex (200mg/Kg.BW) for 2.5 to 3 hour and blood sampling at the time of just before irradiation. The 10B concentration in the blood was measured by prom

Sponsors

Kamitani Nobuhiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) With recurrent skin malignancies that surgical treatment is not indicated or is strongly rejected by patient. 2) The depth of tumor is less than 6cm 3) T/N ratio is more than 2.5 using 18F-BPA-PET. 4) Serum creatinine= 60 percentage

Exclusion criteria

Exclusion criteria: 1) Double cancer with disease-free period less than three years 2) Distant metastases 3) Active infection 4) Adverse events mere than Grade 3 induced by previous therapy 5) Severe heart complications 6) Difficulty of patient fixation for irradiation 7) White blood cell<=3000/mm3, Platelet<=100,000/mm3 8) Unsuitable patients for medical or social situation

Design outcomes

Primary

MeasureTime frame
Tumor response in 6 months after BNCT

Secondary

MeasureTime frame
Adverse events in 6 months after BNCT

Contacts

Public ContactNobuhiko Kamitani

Kawasaki Medical School Hospital

kamitaninobuhiko@gmail.com+81-86-462-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026