Clinical trials on the safety of FMISO-PET

JRCT ID: jRCTs011240047

Registered date:31/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: brain tumor, oral cancer, neuroendocrine tumor or neuroendocrine carcinoma, pheochromocytoma or para
• Date of first enrollment: 31/10/2024
• Target sample size: 70
• Study type: Interventional
• Intervention(s): [18F]FMISO is administered intravenously at a dose of 74-400 MBq, followed by imaging using PET/CT.

Outcome(s)

• Primary Outcome: Percentage of adverse events requiring treatment due to [18F]FMISO administration and their types and severity/frequency.

Secondary Outcome

1. Relationship between treatment response and [18F]FMISO accumulation in patients treated with radiation/chemotherapy by carcinoma
2. Relationship between disease-free survival and [18F]FMISO accumulation by carcinoma
3. Relationship between overall survival and [18F]FMISO accumulation by carcinoma

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Age 20 years or older at the time of obtaining consent.
2. Persons with pathologically diagnosed or suspected malignant tumor (brain tumor, oral cancer, neuroendocrine tumor or neuroendocrine carcinoma, pheochromocytoma or paraganglioma, thyroid cancer).
3. Patients who have one or more measurable lesions on CT or MRI.
4. Persons who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding.

Exclude criteria

1. Pregnant or lactating women, women who are not currently pregnant but may become pregnant and who cannot agree to adequate contraception, or men whose female partner may become pregnant and who cannot agree to adequate contraception
2. Persons with a history of hypersensitivity to [18F]FMISO
3. Patients with severe thrombocytopenia (white blood cell count < 1000/mm3, anemia requiring emergency treatment, platelet count < 25000 mm3)
4. Patients with severe renal dysfunction (creatinine > 6.0 mg/dL, eGFR < 15 mL/min/1.73 m2)
5. Patients with severe hepatic dysfunction (AST > 600 IU/L, ALT > 840 IU/L)
6. Patients weighing less than 20 kg
7. Other patients who are deemed inappropriate as research subjects by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Hirata Kenji