WHO ICTRP trial

The implementation of imaging guidance in surgery for patients with prostate…

EUCTR2020-003183-68-IT · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2020-003183-68-IT
Public title The implementation of imaging guidance in surgery for patients with prostate cancer who are candidate to undergo robot-assisted prostatectomy and lymph node removal
Scientific title The Role of Imaging Guided Surgery to Improve the Detection of LymphNode metastases in Prostate Cancer Patients Treated with Radical Prostatectomy and Extended Pelvic Lymph Node Dissection - PSMA-RGS
Primary sponsor OSPEDALE SAN RAFFAELE
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Italy
Conditions Patients with prostate cancer (PCa) who are candidate to undergo surgical treatment with robot-assisted radical prostatectomy with a risk of lymph nodal invasion > 5% according to preoperative data MedDRA version: 21.1 Level: LLT…
Interventions Product Name: 99mTc-PSMA-I&S Product Code: [99mTc-PSMA-I&S] Pharmaceutical Form: Solution for injection INN or Proposed INN: PSMA I&S (99mTc-MAS3-y-nal-k(Sub-KuE)) Current Sponsor code: 99mTc-PSMA I&S Other descriptive name: PSMA I&S…
Registration date Jun 15, 2021
Target size 100
Secondary IDs PSMA-RGS
Registry page clinicaltrialsregister.eu

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