腎細胞癌患者における89Zr-TLX250を用いたPET/CTイメージングの安全性、生体内分布、感度/特異性の評価

基本情報

NCT ID

NCT04496089

ステータス

完了

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

6

治験依頼者名

Telix Pharmaceuticals (Innovations) Pty Limited

概要

89Zr-TLX250 is a carbonic anydrase IX (CAIX)-targeted imaging agent that is under clinical development as a non-invasive diagnostic imaging agent for teh detection of clear cell renal cell carcinoma (ccRCC). The Phase 1 study part of this study is to confirm the safety/tolerability and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with suspected renal cell carcinoma (RCC) including clear cell renal cell carcinoma. The Phase 2 component of the study is to to evaluate the sensitivity/specificity of using 89Zr-TLX250 PET/CT images to detect RCC and ccRCC in patients with suspected RCC.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)