Phase I Clinical Trial of Prostate-Specific Membrane Antigen-Targeting ⁶⁸Ga-NGUL PET/CT in Healthy Volunteers and Patients with Prostate Cancer.

ABSTRACT:

Objective

⁶⁸Ga-NGUL is a novel prostate-specific membrane antigen (PSMA)-targeting tracer based on Glu-Urea-Lys derivatives conjugated to a 1,4,7-triazacyclononane-N, N', N″-triacetic acid (NOTA) chelator via a thiourea-type short linker. This phase I clinical trial of ⁶⁸Ga-NGUL was conducted to evaluate the safety and radiation dosimetry of ⁶⁸Ga-NGUL in healthy volunteers and the lesion detection rate of ⁶⁸Ga-NGUL in patients with prostate cancer.

Materials and methods

We designed a prospective, open-label, single-arm clinical trial with two cohorts comprising six healthy adult men and six patients with metastatic prostate cancer. Safety and blood test-based toxicities were monitored throughout the study. PET/

SUBMITTER: Suh M 

PROVIDER: S-EPMC9434735 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature