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

NCT06419348 | Recruiting Early Phase 1

• 1 other identifier: CYYY-KY-2023-268
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Stage; PSMA; SPECT

Outcome Measures

Primary Outcomes (1)

• Diagnostic efficacy

  The sensitivity, specificity, and accuracy of 99mTc-QULIC-5-P1 SPECT

  15 days

Study Arms (1)

99mTc-QULIC-5-P1

EXPERIMENTAL

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

Drug: 99mTc-QULIC-5-P1

Interventions

99mTc-QULIC-5-P1 DRUG

Each subject receives a single intravenous injection of 99mTc-QULIC-5-P1.

99mTc-QULIC-5-P1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Central Study Contacts

Xiaoyang Zhang, PhD

CONTACT

023-89011755; zhangxy@mail.bnu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: May 20, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)