Efficacy and Safety of Primovist in Chinese Patients
Ključne riječi
Sažetak
Opis
Adult Chinese patients with known focal or suspected liver lesions, referred for magnetic resonance imaging (MRI) for further diagnostic work-up, who have undergone or are scheduled to undergo a defined SOR procedure, within one month before or after the study MRI.
The data for the Secondary Outcome Measure "Lesion size and location" has been documented but not analyzed. The data for the Secondary Outcome Measure "Safety" are reflected in the Adverse Event section.
Datumi
| Posljednja provjera: | 03/31/2015 |
| Prvo podneseno: | 09/05/2007 |
| Predviđena prijava predata: | 09/05/2007 |
| Prvo objavljeno: | 09/09/2007 |
| Zadnje ažuriranje poslato: | 04/12/2015 |
| Posljednje ažuriranje objavljeno: | 04/30/2015 |
| Datum prvog dostavljanja rezultata: | 10/04/2009 |
| Datum prvog podnošenja rezultata QC: | 11/28/2009 |
| Datum prvog objavljivanja rezultata: | 12/29/2009 |
| Stvarni datum početka studija: | 07/31/2007 |
| Procijenjeni datum primarnog završetka: | 07/31/2008 |
| Predviđeni datum završetka studije: | 07/31/2008 |
Stanje ili bolest
Intervencija / liječenje
Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Faza
Grupe ruku
| Arm | Intervencija / liječenje |
|---|---|
| Experimental: Gadoxetic Acid Disodium (Primovist, BAY86-4873) Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient | Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873) Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient |
Kriteriji prihvatljivosti
| Uzrast podoban za studiranje | 18 Years To 18 Years |
| Polovi podobni za studiranje | All |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | Inclusion Criteria: - Patients between 18 and 75 years of age inclusive. - Patients (men or women) with at least one focal liver lesion, either identified or suspected by ultrasound (US), Computed Tomography (CT)/spiral-CT, conventional angiography, CT-angiography (CTA), CT-arterioportography (CTAP) or unenhanced / contrast-enhanced MRI* within 2 months before entering the study For reference, the following pathologies will meet the definition of 'focal liver lesions': - Hepatocellular carcinoma - Cholangiole carcinoma - Metastasis - Focal lymphoma - Adenoma - Focal nodular hyperplasia - Hemangioma - Abscess - Focal liver fibrosis - Regenerative nodules - Focal fatty infiltration - Hydatid cyst - Liver cyst - Focal sparing in fatty liver - Others - Patients willing to undergo study procedures including safety follow-up - Patients who have undergone or who are scheduled to undergo the defined procedure for SOR within one month before or after the study MRI - Women of child-bearing potential with negative urine pregnancy test result within 24 hours before contrast medium (CM) injection - Patients who are fully informed about the study and have signed the informed consent form Exclusion Criteria: - Patients who have previously entered this study - Patients who have received any contrast material within 24 hours before injection with study drug, or who are scheduled to receive any contrast material within 24 hours after injection - Patients who are, or suspected to be, nursing - Patients who require emergency treatment - Patients with severely impaired hepatic or renal functions (e.g. serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of reference range, acute renal failure) - Patients who are clinically unstable and whose clinical course during the observation period is unpredictable (e.g. due to previous surgery, acute myocardial infarction) - Patients with any physical or mental status that interferes with the signing of informed consent - Patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs - Patients with a contraindication for MRI - Patients who are scheduled for liver biopsy/surgery or other surgeries within 24 hours after injection with contrast media, or who would have a biopsy within 24 hours before planned injection with contrast media - Patients who are likely to have any therapy or change in therapy between the study MRI and the procedures for the SOR |
Ishod
Primarne mjere ishoda
1. Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Measured as Percentage Points [Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).]
Sekundarne mjere ishoda
1. Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Assessed by Investigators Measured in Percentage Points [Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).]
2. Difference in Precision of Lesion Characterization (Combined Pre- and Post-contrast Minus Pre-contrast MRI) Measured in Percentage Points [Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).]
