Actively Recruiting

Early Phase 1
Age: 18Years +
MALE
Healthy Volunteers
ID06419348

99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer and Compared With 68Ga-PSMA-11 PET

Led by First Affiliated Hospital of Chongqing Medical University · Updated on 2025-06-04

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new imaging agent called 99mTc-QULIC-5-P1, a radiotracer that targets PSMA, which may help detect lesions in patients with PSMA positive prostate cancer. This early phase 1 study aims to investigate the safety, how the agent spreads in the body, and its usefulness in imaging prostate cancer compared with a standard PET scan agent called 68Ga-PSMA-11. Participants will receive a single intravenous injection of 99mTc-QULIC-5-P1. The study involves one study group where this radiotracer is administered once, followed by imaging procedures to assess its diagnostic capabilities. The comparison with 68Ga-PSMA-11 PET imaging will help understand the performance of the new tracer. During the study, participants will undergo diagnostic imaging to evaluate the presence and location of prostate cancer lesions. Researchers will monitor safety and efficacy outcomes over 15 days, focusing on diagnostic effectiveness. The study includes consent procedures and excludes those with certain medical conditions or lack of PSMA expression. Total participation duration varies but includes initial administration and follow-up for outcome assessment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age
  • Signed informed consent
  • Patients with suspected, newly diagnosed, or previously diagnosed prostate cancer with PSMA positive expression confirmed by MRI, CT, pathology, or similar evidence
Not Eligible

You will not qualify if you...

  • Patients with PSMA negative expression
  • Patients who are pregnant
  • Inability or unwillingness to provide written informed consent
  • Known or expected hypersensitivity to 99mTc-QULIC-5-P1 or any of its components
  • Any serious medical condition that may interfere with study procedures or evaluations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants receive a single intravenous injection of 99mTc-QULIC-5-P1 to assess prostate cancer through SPECT imaging.

1 visit (in-person)

Long-term Monitoring

Duration - 15 days

Participants are monitored for diagnostic efficacy and safety over the following 15 days.

Follow-up assessments during this period

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400016

Actively Recruiting

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Research Team

X

Xiaoyang Zhang, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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