Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor

Phase 2

Recruiting

• Conditions: Malignancy
• Interventions: Drug: Al18F-PSMA-BCH PET/CT

• Registration Number: NCT05761366
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

In this study, Al18F-PSMA-BCH PET/CT will be performed in patients with prostate specific membrane antigen positive tumor, to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.

Detailed Description

Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors (including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.) , to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.

Study Timeline

• Study Start: 2022-10-13
• Study First Submitted: 2023-02-19
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-21
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-10-13
• Study Completion: 2025-10-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Patients with suspected or clearly diagnosed PSMA positive-expressing tumors, including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.
2. Age is 18 or older; No gender limitation.
3. Signed the informed consent.
4. Willing and able to cooperate with all projects in this study.

Exclusion Criteria

1. Patients with serious neurological diseases,or gastrointestinal tract disease, cardiovascular disease, liver disease, kidney disease, blood system disease, endocrine system disease, respiratory system disease, immune deficiency disease, etc
2. Claustrophobia.
3. Pregnant or lactation women.
4. Received experimental drug or device within 1 month.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Al18F-PSMA-BCH PET/CT	Al18F-PSMA-BCH PET/CT	Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors.（including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.）

Primary Outcome Measures

Name	Time	Method
Diagnostic value	through study completion, an average of 1 year	Sensitivity and Specificity of 18F-PSMA PET / CT for the diagnosis of Prostate Specific Membrane Antigen Positive Tumor

Trial Locations

Locations (1)

National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Chaoyang, China