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The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients With ACC- an Open, Non-commercial Clinical Trial — LuRM_ACC/2023  

Adenoid Cystic Carcinoma Clinical Trial

Official title:
The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a Specialized Prostate-specific Membrane Antigen (PSMA) Labeled With Lutetium177, in Patients With Recurrent and/or Metastatic Adenoid Cystic Carcinoma Originating From the Salivary Glands - an Open, Non-commercial Clinical Trial

Clinical Trial Summary

Non-commercial phase 2 clinical trial to evaluate the effectiveness, safety and tolerability of treatment using prostate-specific membrane antigen (PSMA) labeled with 177Lutetium in patients with recurrence and/or metastases in adenoid cystic carcinoma originating from the salivary glands of the head and neck region. Patients with PSMA receptor expression confirmed by PET/CT after administration of 68Ga-PSMA I&T will be eligible for treatment.

Clinical Trial Description

It is planned to enroll 32 patients diagnosed with non-resectable recurrence and/or dissemination in the course of ACC, whose general condition and life expectancy justify qualification for diagnosis using PSMA 68Ga and treatment with lutetium (177Lu) vipivotide-tetraxetan The Study assumes the administration of 6 cycles of treatment (lutetium [177Lu] vipivotide-tetraxetan) at 6-week intervals. If toxicity occurs, the activity of the next dose of the preparation will be modified or its next administration will be delayed by a maximum of 4 weeks. After completing 6 cycles of therapy, the participant enters the observation phase, which will last until recurrence of the disease is diagnosed or for 2 years after the end of therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06199453
Study type Interventional
Source Maria Sklodowska-Curie National Research Institute of Oncology
Contact Marek Kentnowski
Phone 48322788319
Email marek.kentnowski@gliwice.nio.gov.pl
Status Not yet recruiting
Phase Phase 2
Start date January 2024
Completion date November 2027
View Details
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