Study of BNCT for Positive Tumors

JRCT ID: jRCTs031240204

Registered date:05/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: FDG-PET Positive Superficial Tumors
• Date of first enrollment: 10/08/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Boron Neutron Capture Therapy

Outcome(s)

• Primary Outcome: Efficacy: response rate
• Secondary Outcome: Safety: Acute adverse events for safety evaluation criteria

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Kurosaki Hiromasa
• Secondary Sponsor: Edogawa Hospital