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Study on the biodistribution, radiation dose, safety and preliminary diagnostic efficacy of 68Ga-labeled acidic phosphatase 3 (ACP3) targeting probe (68Ga-FC516) in healthy subjects and prostate cancer patients

Study on the biodistribution, radiation dose, safety and preliminary diagnostic efficacy of 68Ga-labeled acidic phosphatase 3 (ACP3) targeting probe (68Ga-FC516) in healthy subjects and prostate cancer patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122773
Enrollment
Unknown
Registered
2026-04-17
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Prostate cancer

Interventions

Group A:Administer 68Ga-FC516 injection and perform PET/CT imaging
Group B:Administer 68Ga-FC516 and 68Ga-PSMA11 or 68Ga-OnCoACP3 injections, and perform PET/CT imaging.

Sponsors

The First Affiliated Hospital, Jinan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.The subjects voluntarily signed the informed consent form and were able to complete the trial as per the protocol requirements. 2.Age: 18 years old and above; 3.Group A: Healthy subjects; Group B: Patients diagnosed with prostate cancer through pathological tissue or cytological examination; 4.If the patient with prostate cancer has tissue samples, the samples need to be provided for the assessment of ACP3 expression. 5.Qualified patients with reproductive capacity must agree to use a reliable contraceptive method (hormonal, barrier, or abstinence) with their partners during the trial period and for at least 3 months after the last medication administration.

Exclusion criteria

Exclusion criteria: 1.Those with severe liver, kidney and heart dysfunction; 2.Patients with severe obesity and those who cannot or are unable to undergo PET/CT scans; 3.Allergic to any active or inactive ingredients of the studied drug; 4.Other researchers consider the subjects who are not suitable for inclusion in the study; 5. Underwent major organ surgery (excluding biopsy) or experienced significant trauma within 4 weeks prior to the first dose, or requires elective surgery during the trial.

Design outcomes

Primary

MeasureTime frame
SUV value;

Secondary

MeasureTime frame
Residence time;

Countries

China

Contacts

Public ContactLu Wang

The First Affiliated Hospital, Jinan University

l_wang1009@jnu.edu.cn+86 20 3868 8994

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026