TheranosticTrials.org

Clinical Trial · NCT07365397

Imaging Characteristics of Different ⁶⁸Ga-PSMA Probes in Prostate Cancer

Overview

This study aims to evaluate the imaging characteristics of \[⁶⁸Ga\]Ga-GS24-B2-250-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-250-T), \[⁶⁸Ga\]Ga-GS24-B2-268-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-268-T), \[⁶⁸Ga\]Ga-GS24-B2-237-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-237-T), and \[⁶⁸Ga\]Ga-PSMA-11 Injection (abbreviated as ⁶⁸Ga-PSMA-11) as PET/CT imaging agents in patients with prostate cancer.

Sponsor

Shanghai East Hospital

Phase

N/A

ClinicalTrials.gov

NCT07365397

Drug / Compound

GS24-B2-250-T

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

GS24-B2-237-T

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

GS24-B2-268-T

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
  • Presence of positive lesions on ⁶⁸Ga-PSMA-11 PET/CT scan;
  • Blood routine, renal function, and liver function tests meeting the following criteria:
  • Expected survival time ≥ 6 months;
  • Platelet count \> 90 × 10⁹/L;
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 × ULN;
  • Urea/urea nitrogen and serum creatinine \< 1.5 × upper limit of normal (ULN);
  • Clinically or radiologically assessed as metastatic hormone-sensitive prostate cancer (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC);

Exclusion

  • Having received high-energy γ-ray-emitting agents (\>300 KeV, e.g., radiopharmaceuticals labeled with radionuclides such as \[¹³¹I\]I, \[¹⁸F\]F, \[⁶⁸Ga\]Ga, \[⁶⁴Cu\]Cu, etc.) within a period equivalent to either 5 half-lives of the agent or 2 days, whichever is longer, prior to administration.
  • Having any medical condition or other circumstances that, in the investigator's judgment, may affect the safety or compliance of the subject.
  • Planning to adjust anti-tumor medication during the study period.
  • Having received any intravenous iodine-containing contrast agent within 24 hours prior to administration, or any high-density oral contrast agent (e.g., barium sulfate) within 5 days prior to administration. Oral water-soluble contrast agents (e.g., compound meglumine diatrizoate oral solution) are acceptable.
  • Being unable to complete the required PET/CT imaging procedures.