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Clinical trials on the safety of FMISO-PET

A Single-Center, Uncontrolled, Exploratory Clinical Study of the Safety of the Radioligand [18F]-Fluoromisonidazole as an Intratumoral Hypoxic Imaging Agent

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs011240047
Enrollment
70
Registered
2024-10-31
Start date
2024-10-31
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

brain tumor, oral cancer, neuroendocrine tumor or neuroendocrine carcinoma, pheochromocytoma or para FMISO

Interventions

[18F]FMISO is administered intravenously at a dose of 74-400 MBq, followed by imaging using PET/CT.

Sponsors

Hirata Kenji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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 6.0 mg/dL, eGFR 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.

Design outcomes

Primary

MeasureTime frame
Percentage of adverse events requiring treatment due to [18F]FMISO administration and their types and severity/frequency.

Secondary

MeasureTime frame
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

Contacts

Public ContactShiro Watanabe

Hokkaido University Hospital

shirow@med.hokudai.ac.jp+81-11-706-7779

Outcome results

None listed

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