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A safety and biodistribution study of 111In-FXN001 in health men and metastatic castration-resistant prostate cancer patients

A safety and biodistribution study of 111In-FXN001 in health men and metastatic castration-resistant prostate cancer patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200064446
Enrollment
Unknown
Registered
2022-10-08
Start date
2022-10-15
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

Gold Standard:68Ga-PSMA
Index test:FXN001

Sponsors

The Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The male aged >= 18 years, with confirmed mCRPC; 2. Patients with expected survival >= 6 months; with ECOG score of 0, 1, or 2; 3. At least 1 metastatic lesion (on CT or whole-body bone imaging); 4. Patients whose blood routine and liver and kidney function meet the following criteria: blood routine: WBC >= 4.0 x 10^9/L or neutrophil >= 1.5 x 10^9/L, PLT >= 100 x 10^9 / L, Hb >= 90g / L; PT or APTT <= 1.5 ULN; liver and kidney function: T-Bil <= 1.5 ULT (upper limit of normal value), ALT / AST <= 2.5 ULN or <= 5 ULT (liver metastasis patients), ALP <= 2.5 ULN (if there is bone metastasis or liver metastasis, ALP <= 4.5 ULN), bun <= 1.5 ULT, SCR <= 1.5 ULT; 5. Patients with at least one measurable target lesion according to recist 1.1; 6. Men should agree to take contraceptive measures during the study period and within 6 months after the end of the study period; 7. Patients who can understand and voluntarily sign informed consent and have good compliance.

Exclusion criteria

Exclusion criteria: 1. Can not lie flat for half an hour; 2. Suffering from claustrophobia or other mental illness; 3. Conditions deemed unsuitable for participation by other researchers.

Design outcomes

Primary

MeasureTime frame
Tumor / non-tumor tissue ratio(T/NT);Maximum standardized uptake value;

Countries

China

Contacts

Public ContactChen Yue

The Affiliated Hospital of Southwest Medical University

chenyue5523@126.com+86 830 3165720

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026