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Resovist

Phase 3

Hepatic Neoplasms | Unknown | Oncology |Bayer AG|Last Updated: May 18, 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment218

FDA Designations

No designations recorded

Clinical trial landscape

Resovist · 1 trial · 1 indication

Phase 3 1
NCT00307866Identification of Hepatic LesionsHepatic Neoplasms
COMPLETED218 Analytics
PHASE3COMPLETED
Identification of Hepatic Lesions
Hepatic NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

Secondary Endpoints

To assess the number, size , location and character of liver lesions.
To assess the diagnostic confidence of MRI and CT.
To assess the proportion of changed therapeutical decisions.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
Resovist (BAY86-4884, SH U 555 A)PROCEDURESingle bolus injection, followed by MRI
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: 1. 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 condi...

Countries:Italy
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Frequently asked questions about Resovist

What is Resovist used for?

Resovist is used for the identification of hepatic lesions in patients with hepatic neoplasms, which are tumors or abnormal growths in the liver. It is an investigational agent that has been studied in a clinical trial setting for this purpose.

Who makes Resovist?

Resovist is developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the over-the-counter market.

What phase is Resovist in?

Resovist is in Phase 3 of clinical development. It has completed a Phase 3 clinical trial, but it is still considered investigational and has not been approved by regulatory authorities.

What clinical trials is Resovist in?

Resovist has been studied in one completed Phase 3 clinical trial with the identifier NCT00307866, titled 'Identification of Hepatic Lesions.' This trial enrolled 218 participants with hepatic neoplasms and was conducted in Italy.

Is Resovist FDA approved?

Resovist is not FDA approved. It is an investigational agent that has completed a Phase 3 clinical trial, but it remains in clinical development and has not received approval from the U.S. Food and Drug Administration or other regulatory bodies.