Study Completed

Hepatic Neoplasms

Bayer Identifier:

90956

ClinicalTrials.gov Identifier:

NCT00307866

EudraCT Number:

Not Available

EU CT Number:

Not Available

Identification of hepatic lesions

Trial purpose

Patients with suspicion of primary or secondary hepatic malignancy in whom a radiological examination is needed in order to decide on the most appropriate treatment.

Key Participants Requirements

Sex

Both

Age

18 Years

Inclusion Criteria
- Present with suspicion of primary or secondary hepatic malignancy in whom a radiological examination is needed in order to decide on the most appropriate treatment.
- There should not be more than five liver lesions on type visualized on CT.
- The patient should be in a condition that allows subsequent treatment.
- Be willing and able to continue study participation following administration of SH U 555 A to ensure completion of all procedures and observations required by the trial protocol.
- Sign and date fully informed consent prior to entry into the study.
Exclusion Criteria
- Patients under 18 years of age.
- Patients weighing less than 35 kg.
- Patients who have received any investigational drug within the 30 days prior to entering this study.
- Patients who have previously entered this study or any other study performed with SH U 555 A.
- Women who are pregnant or who are of childbearing potential and have not had a negative urine pregnancy test immediately prior to the administration of SH U 555 A. The urine pregnancy test should be performed in accordance with the manufacturer's recommendations.
- Lactating women.
- Patients who have any contraindication to MRI examination.
- Patients who have received any contrast material in the 24 hours prior to SH U 555 A injection, or who are scheduled to receive any contrast material within 24 hours afterwards. (In the case of any liver specific agent (e.g. MnDPDP, SPIOs, Gd-BOPTA) this will be extended to 14 days prior to the study).
- Patients who have received Lipiodol contrast material at any time in the past or are scheduled to receive this during the study period.
- Patients who are clinically unstable and whose clinical course during the observation period is unpredictable (e.g. due to previous surgery).
- Patients scheduled for liver biopsy within 24 hours, or who had a biopsy within the 24 hours prior to planned SH U 555 A injection.
- Patients who are scheduled for, or are likely to require, surgery within 24 hours after SH U 555 A injection.
- Patients with a history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
- Patients with known hypersensitivity to any of the ingredients of SH U 555 A.
- Patients with already clear op-indication

Trial summary

Enrollment Goal

218

Trial Dates

April 2001 - May 2003

Phase

Phase 3

Could I Receive a placebo

Products

Resovist (Ferucarbotran, BAY86-4884)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Ospedale di Cattinara	Trieste, 34149, Italy
Completed	Policlinico Universitario di Udine	Udine, 33100, Italy
Completed	Spedali Civili di Brescia	Brescia, 25123, Italy
Completed	Policlinico Careggi	Firenze, 50100, Italy
Completed	Università G.D'Annunzio	Chieti, 66100, Italy
Completed	Policlinico S.Orsola-Malpighi	Bologna, 40100, Italy
Completed	Università La Sapienza	Roma, 00161, Italy
Completed	Università di L'Aquila	L'Aquila, 67100, Italy
Completed	Policlinico Universitario Giaccone	Palermo, Italy
Completed	Istituto Europeo di Oncologia	Milano, Italy
Completed	Ospedale Sant'Eugenio	Roma, 00144, Italy
Completed	Policlinico Consorziale	Bari, 70124, Italy
Completed	Ospedale S.G. Battista Le Molinette	Torino, 10154, Italy
Completed	Ospedale San Paolo	Milano, 20142, Italy
Completed	Policlinico S.Orsola-Malpighi	Bologna, 40100, Italy
Completed	Ospedale Santa Chiara	Pisa, 56126, Italy
Completed	Ospedale San Raffaele	Milano, 20132, Italy
Completed	Policlinico Borgo Roma	Verona, 37134, Italy
Completed	Università di Sassari	Sassari, 07100, Italy
Completed	A.O.U. San Martino genova	Genova, 16132, Italy

Primary Outcome

To assess the proportion of correct final, therapy deciding diagnosis based on unenhanced plus SH U 555 A enhanced MR imaging compared to contrast-enhanced dual-phase spiral CT.
Safety Issue:
None

Secondary Outcome

To assess the number, size , location and character of liver lesions.
Safety Issue:
None
To assess the diagnostic confidence of MRI and CT.
Safety Issue:
None
To assess the proportion of changed therapeutical decisions.
Safety Issue:
None
To assess sensitivity and specificity of MRI and CT.
Safety Issue:
None
To assess safety and tolerability of SH U 555 A administration.
Safety Issue:
None

Trial design

A prospective, multicenter, phase III b clinical study to evaluate the effectiveness of unenhanced and SH U 555A (Resovist) enhanced MRI, compared to contrast-enhanced dual-phase spiral CT in assessing the correct final therapy-deciding diagnosis, in patients with primary or secondary hepatic malignancies.

Trial Type

Interventional

Intervention Type

Procedure/Surgery

Trial Purpose

Diagnostic

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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