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Recruiting NCT06419348

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

Early Phase I Interventional Prostate Cancer Stage PSMA SPECT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 99mTc-QULIC-5-P1.
Who it may be relevant to
Registry conditions: Prostate Cancer Stage, PSMA, SPECT. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Diagnostic efficacy [Time frame: 15 days]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing

Identifiers

NCT: NCT06419348 · CYYY-KY-2023-268

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗