1. Lymph node metastases will be detected by MRI scan (Ferumoxtran-10-enhanced and unenhanced). (Time Frame - up to day 42): True positive fraction and false positive fraction of identified tumour tissue in pelvic lymph nodes will be analysed by histopathology as established reference method.
Secondary outcome:
1. Number and regions of lymph node metastases present in the follow-up MRI in comparison to pre-surgery MRI (unenhanced and Ferrotran®-enhanced). (Time Frame - up to day 105)
2. Frequency of occurrence and severity of abnormal findings in safety investigations (physical examination, vital signs, 12-lead ECG, clinical laboratory, concomitant medication, adverse events) (Time Frame - day 0 - day 105)
3. Percentage of subjects for whom the patient management plan would be changed based on the Ferrotran®-enhanced MRI. (Time Frame - up to day 105)
Ferrotran® (Ferumoxtran-10) (Ferrotran Lyophilisate): Ferrotran® in a dose of 0.13 mL/kg body weight of the reconstituted freeze-dried preparation (i.e. 2.6 mgFe/kg body weight). The recommended dose should be diluted in 100 mL of NaCl 9 mg/mL (0.9%) solution for injection/infusion prior to administration via the infusion filter as a slow intravenous infusion over 30 minutes (at a maximum rate of 4 mL/min).
Ferrotran® will be administered once to each patient. Histologically confirmed diagnosis and pre-operative staging are performed prior to the study as part of standard care. Surgery (RP with ePLND) and sampling of tissue specimens is performed after the Ferrotran®-enhanced MRI as part of standard care.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients"
Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.
Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!
