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Study of BNCT for Positive Tumors

Pilot study of Boron Neutron Capture Therapy For FDG-PET Positive Superficial Tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031240204
Enrollment
10
Registered
2024-07-05
Start date
2024-08-10
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

FDG-PET Positive Superficial Tumors FDG-PET Positive Tumors

Interventions

Sponsors

Kurosaki Hiromasa
Lead Sponsor
Edogawa Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Written consent for participation in this study has been obtained from the subject or a surrogate at the time consent is obtained. 2) The following patients with Malignant tumor 1. Patients with lesions with a distance of 6 cm or less from the skin surface to the deepest part of the tumor which two nuclear radiologists agree to detect FDG up-take. 2. Patients who have one or more lesions of a size detected by CT or MRI. 3. Patients who are not adversely affected by withdrawal of chemotherapy (including molecular-targeted agents and not hormonal therapy) for more than 4 weeks prior to BNCT treatment. 4. Patients with no evidence of serious cardiac complications on resting 12-lead ECG

Exclusion criteria

Exclusion criteria: 1) Patients who have received more than 75Gy of radiotherapy to the lesion area in the prior treatment of the target lesion. 2) Patients with Palliative Prognostic Index of 4 or more if have the lesion out of irradiation area. 3) Patients with measurable tumor skin exposure greater than 5 cm 4) Patients with NYHA cardiac function classification grade III or IV 5) Patients with pulmonary fibrosis or interstitial pneumonia have severe symptoms or are limited in activities of daily living, need oxygen inhalation.

Design outcomes

Primary

MeasureTime frame
Efficacy: response rate

Secondary

MeasureTime frame
Safety: Acute adverse events for safety evaluation criteria

Contacts

Public ContactHiromasa Kurosaki

Edogawa Hospital

h.kurosaki@edogawa.or.jp+81-3-3673-1221

Outcome results

None listed

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