Calendario›LNTH›BAY86-9596

BAY86-9596

PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.

Ensayo de Lantheus Holdings, Inc. en Diagnostico por imagen.

Fase

Fase 1

Estado

Completado

Participantes

24

previstos

Centros

2

Fin del objetivo primario

dic 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en may 2011.

Qué mide

BAY86-9596 lesion detection rate (overall number of lesions identified). (del registro, en inglés) (hasta 2 horas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe study will be conducted as an open label, single-center, single dose and biodistribution study in patients with cancer or inflammation. 56 patients will be selected among the patients undergoing the screening examination conducted within 3 weeks before drug administration. Single dose of the study drug will be administrated in a dose of 300 MBq to these patients. The follow-up period contains the end-of-study telephone interview 5-8 days following the treatment. Key measurements are the PET/CT image acquisitions within a time frame of about 2 hours after the single injection of BAY86-9596.

Más ensayos de LNTH

Todos los de LNTH, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01297088), actualizada en ene 2013.