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[68Ga]RM2

PET/CT Imaging Study of the Safety and Diagnostic Performance of [68Ga]RM2 in Patients With Primary Prostate Cancer

Ensayo de Lantheus Holdings, Inc. en Cancer de prostata.

Más ensayos de: Cáncer de próstata.

Fase

Fase 1/2

Estado

Interrumpido

Participantes

30

previstos

Centros

2

Fin del objetivo primario

dic 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en may 2015.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Business decision».

Qué mide

Sensitivity and specificity of [68Ga]RM2 PET to identify lesions in comparison to whole-mount histopathology (number of histologically verified cancer lesions identified) (60-80 min post injection) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe aim of this study is to investigate safety and diagnostic performance of the 68Ga labeled PET tracer \[68Ga\]RM2 for detection and localization of primary prostate cancer confirmed by histopathology of the prostate as a standard of truth. This is an open-label, multi center PET/CT (positron emission tomography/computed tomography) non-randomized study. The study comprises 2 parts with an interim analysis after Part 1. In Part 1 a total of 30 subjects with biopsy-proven primary prostate cancer will be enrolled. Three strata of patients for the first part will be enrolled based on their pretreatment recurrence risk assessment according to the NCCN guidelines: 10 patients with low, 10 patients with intermediate and 10 patients with high pretreatment risk of recurrence.

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Todos los de LNTH, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02483884), actualizada en mar 2017.