99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer

Early Phase 1

Recruiting

• Conditions: PSMA; Prostate Cancer Stage; SPECT
• Interventions: Drug: 99mTc-QULIC-5-P1

• Registration Number: NCT06419348
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

Brief Summary

99mTc-QULIC-5-P1 is a new radiotracer targeting PSMA, which is promising as an excellent imaging agent applicable to PSMA positive prostate cancer. This study will investigate the safety, biodistribution and potential usefulness of 99mTc-QULIC-5-P1 SPECT imaging for the diagnosis of lesions in PSMA positive prostate cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-17
• Study Start: 2024-05-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-06-04
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1. At least 18 years of age.
2. Signed informed consent.
3. Patients with suspected or newly diagnosed or previously prostate cancer, with PSMA positive expression (supporting evidence may include MRI, CT, and pathology report, etc).

Exclusion Criteria

1. Patients with PSMA negative expression.
2. Patients with pregnancy.
3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
4. Known or expected hypersensitivity to 99mTc-QULIC-5-P1 or any of its components.
5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
99mTc-QULIC-5-P1	99mTc-QULIC-5-P1	Patients will receive a single administration of 99mTc-QULIC-5-P1

Primary Outcome Measures

Name	Time	Method
Diagnostic efficacy	15 days	The sensitivity, specificity, and accuracy of 99mTc-QULIC-5-P1 SPECT

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China