The Exploration of 18F-PSMA-1007 PET/CT Imaging in Prostate Cancer Patients

NCT06723665 | Enrolling By Invitation

• 1 other identifier: LS2024279
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

micro-PET imaging showed that 18F-PSMA-1007 had similar or even better pharmacokinetics and imaging performance than 18F-DCFPyL. Due to the convenience of synthesis and good imaging performance, 18F-PSMA-1007 is expected to be popularized in clinical practice.The purpose of this study is to evaluate the performance of 18F-PSMA-1007 in diagnosis, differential diagnosis and efficacy monitoring of prostate cancer.

Conditions

Prostate Cancer

Keywords

prostate cancer; PET/CT; PSMA-1007; 18F

Outcome Measures

Primary Outcomes (1)

• 18F-PSMA-1007 PET/CT and 18F-FDG PCT/CT imaging were compared to determine the advantages of 18F-PSMA-PSMA PET/CT imaging for prostate cancer

  For patients receiving 18F-PSMA-1007 PET/CT, 18F-FDG PET/CT imaging was performed, and image visual analysis, semi-quantitative analysis and prognostic study were performed on PET/CT images. To evaluate the diagnosis, staging and prognosis of 18F-PSMA-1007

  1 day

Study Arms (2)

18F-PSMA-1007

EXPERIMENTAL

Subjects: Patients with suspected or diagnosed prostate cancer, or biochemical recurrence of prostate cancer. Over 40 years old (including 40 years old); Informed consent and access to follow-up; To exclude patients who are difficult to receive further diagnosis and treatment because of their serious condition. PSMA PET/CT was reviewed 7 days and 3 months after surgery. All patients were followed up once every 3 months to understand the progression and survival of the lesions.

Drug: 18F-PSMA-1007

18F-FDG

ACTIVE COMPARATOR

The corresponding patients underwent PSMAPET/CT examination within one week before and after routine 18F-FDGPCT/CT imaging (control examination). PCT/CT whole body scan was performed 45min-1h after intravenous injection of the developer, and the image processing was as usual.

Drug: 18F-FDG

Interventions

18F-PSMA-1007 DRUG

18F-PSMA-1007 is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15mCi/kg

18F-PSMA-1007

18F-FDG DRUG

18F-FDG is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15mCi/kg

18F-FDG

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostate cancer is clinically suspected. The patient was diagnosed with prostate cancer by biopsy. Prostate cancer needs to be evaluated after treatment.

You may not qualify if:

• Patients who did not meet the requirements as assessed by the investigator.

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Affiated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: January 25, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 24, 2025

Record last verified: 2024-12

Locations

CN (1)