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The efficacy of [18F]AlF-Bi-PSMA PET/MR in the diagnosis and staging of prostate cancer

The efficacy of [18F]AlF-Bi-PSMA PET/MR in the diagnosis and staging of prostate cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300067800
Enrollment
Unknown
Registered
2023-01-28
Start date
2023-02-01
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

Index test:[18F]AlF-Bi-PSMA PET/MR, [18F]PSMA-1007 PET/MR

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years old; 2. Patients with elevated PSA or other conditions that need to be considered for prostate malignancy (refer to the 2020 NCCN guidelines and the 2014 Chinese guidelines); 3. Patients with biochemical recurrence after radical prostatectomy (PSA>0.2); 4. Patients with castration-resistant prostate cancer; 5. Re-examination of prostate cancer patients after treatment; 6. Able to withstand magnetic resonance examination and have good compliance; 7. Sign the informed consent form for the inspection and undergo the [18F] AlF-Bi-PSMA PET/MR examination.

Exclusion criteria

Exclusion criteria: 1. Those with other malignant tumors during imaging; 2. Those who cannot lie flat for half an hour; 3. Suffering from claustrophobia or other psychiatric disorders; 4. Refusal or inability to tolerate prostate puncture examination halfway; 5. Those who are allergic to imaging agents; 6. Those with contraindications to MRI, such as MR-incompatible grafts (pacemakers, insulin pumps, cochlear implants, joint prostheses, etc.) in vivo); 7. Other cases where the investigator deems it inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
The number of lesions and the SUV, SEN, SPE, ACC, AUC of ROC;Sensitivity;Diagnostic efficacy of prostate cancer;Specificity;positive predictive value;

Countries

China

Contacts

Public ContactPengcheng Ran

Guangdong Provincial Hospital of Traditional Chinese Medicine

cmurpc@163.com+86 137 5170 1540

Outcome results

None listed

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