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Exploratory study of [18F]DiFA for cancer patients

Exploratory study of [18F]DiFA for cancer patients - Exploratory study of [18F]DiFA

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029507
Enrollment
10
Registered
2017-10-17
Start date
2017-11-06
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

cancer

Interventions

[18F]FMISO Dose: 320-400 MBq Injected quantity: 5 mL (Maximum) Administration method: Single intravenous dose [18F]DiFA Dose: 600-740 MBq Injected quantity: 3 mL (Maximum) Administration meth

Sponsors

Hokkaido University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients diagnosed with cancer in a doctor's visit to Hokkaido University Hospital or in Hokkaido University Hospital stay. Satisfy the following conditions; (1)aged 20-70 years old at agreement acquisition. (2)gave a written informed consent. (3)diagnosed with cancer with clinical manifestation, clinical course, imaging, and histo-pathological examination. (4)confirmed the lesion in CT, MRI or FDG-PET.

Exclusion criteria

Exclusion criteria: (1) Pregnant women, breast-feeding women, or women who may be pregnant. (2)with hepatic or renal disease. (3) Karnofsky performance status(KPS) under 40. (4) an acute disease symptom (nausea, vomiting, fever, diarrhea) within 3 days before administering. (5) a history of hypersensitivity for medical drugs. (6) a participation in other clinical trials at present or within 6 months (180 days) before consent. (7) diagnosed by [18F]DiFA-PET within 90 days before consent. (8) a history of drug abuse or alcoholism. (9) considered as inappropriate for this study.

Design outcomes

Primary

MeasureTime frame
To compare [18F]DiFA accumulation with [18F]FMISO accumulation to hypoxia region in tumor.

Secondary

MeasureTime frame
1)To clarify the presence or the absence, the type, the severity, and frequency of adverse effects and to assess the shift of laboratory test values by the administration of [18F]DiFA. 2)To estimate the optimum amount of radioactivity and imaging time of [18F]DiFA PET for cancer patient.

Countries

Japan

Contacts

Public ContactTohru Shiga

Hokkaido University, Graduate School of Medicine N15, W7, Kita-Ku, Sapporo

tshiga@med.hokudai.ac.jp011-706-5152

Outcome results

None listed

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