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A Diagnostic Trial Study of Novel PET/CT Imaging Targeting Acid Phosphatase for Prostate Cancer

A Diagnostic Trial Study of Novel PET/CT Imaging Targeting Acid Phosphatase for Prostate Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125732
Enrollment
Unknown
Registered
2026-05-29
Start date
2026-05-31
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Prostate cancer

Interventions

Index test:[18F]FDG PET/CT imaging and ACP3-HKZ PET/CT imaging

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Research participants voluntarily participate in this study and sign an informed consent form. 2. Aged 18-75 years old (based on the date of signing the informed consent form). 3. The primary inclusion criteria for patients are a pathologically confirmed prostate cancer diagnosis or clinical manifestations and other imaging examinations indicating suspected prostate cancer that needs confirmation. 4. Expected survival time is more than 12 weeks. 5. Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC >= 4.0 × 10^9/L or neutrophils >= 1.5 × 10^9/L, PLT >= 100 × 10^9/L, Hb >= 90 g/L; PT or APTT <= 1.5 ULN; Liver and kidney function: T-Bil <= 1.5 × ULN (upper limit of normal), ALT/AST <= 2.5 ULN or <= 5 × ULN, ALP <= 2.5 ULN (if there are bone or liver metastases, ALP <= 4.5 ULN); BUN <= 1.5 × ULN, SCr <= 1.5 × ULN. 6. Willing and able to comply with the diagnostic plan, clinical laboratory tests, and other study procedures.

Exclusion criteria

Exclusion criteria: 1.Critically ill emergency patients; severe respiratory failure or airway obstruction due to respiratory diseases. 2.Presence of contraindications to PET/CT scanning, including but not limited to: poorly controlled elevated blood glucose; known allergy to radiopharmaceuticals or their excipients (including a history of severe allergic or anaphylactic reactions, especially allergy to the study drug). 3.Patients who cannot tolerate or have not successfully completed previous clinical examinations. 4.Previous use of radionuclides with an interval of less than 10 physical half-lives before administration in this study. 5.Deemed unsuitable for participation in this study by the investigator. 6.Patients with a second primary tumor.

Design outcomes

Primary

MeasureTime frame
Specificity;Sensitivity;Accuracy;

Countries

China

Contacts

Public ContactDong Mengjie

Peking University Shenzhen Hospital

Dongmengjie@126.com+86 18257173283

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026