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NCT Number: NCT06419348

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

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.

Recruiting

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Key information

Conditions

Prostate Cancer Stage PSMA SPECT

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location status: Recruiting

Location contact

Xiaoyang Zhang, PhD

CONTACT

[email protected]

023-89011755

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

99mTc-QULIC-5-P1

Drug

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

Primary outcomes

  1. Diagnostic efficacy

    Time frame: 15 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoyang Zhang, PhD

CONTACT

[email protected]

023-89011755

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 17, 2024
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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