A PROSPECTIVE MULTICENTER COHORT STUDY EVALUATINGTHE LONG TERM RETENTION OF GADOLINIUM IN HUMAN BONE AND SKIN AFTER THE RETROSPECTIVE ADMINISTRATION OF MULTIHANCE® OR PROHANCE® IN COMPARISON WITH A CONTROL GROUP RECEIVING NO EXPOSURE TO GADOLINIUM

Bracco Imaging S.p.A.0 sites36 target enrollmentFebruary 26, 2013

Overview

No summary available.

Registry

who.int

Start Date

February 26, 2013

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•SUBJECTS WHO RECEIVED MULTIHANCE or PROHANCE
•Is scheduled to receive hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
•Has undergone at least one MULTIHANCE or PROHANCE administration at least 1 month before his/her scheduled surgery
•Has a documented SCr for calculation of eGFR and/or documented eGFR at time of last MRI with MULTIHANCE or PROHANCE
•Provides written Informed Consent and is willing to comply with protocol requirements
•Is willing to undergo deep skin tissue sampling during scheduled hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
•Is \=18 years of age
•SUBJECTS WITH NO EXPOSURE TO GBCA
•Is scheduled to receive hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
•Has no history of GBCA administration

•SUBJECTS WHO RECEIVED MULTI HANCE or PROHANCE
•Has undergone any GBCA including MULTIHANCE or PROHANCE administration less than 1 month before his/her scheduled surgery
•Has ever been suspected of, or diagnosed with, NSF
•Has been suspected or diagnosed, prior to inclusion in this study, with bone cancer or any other osteoblastic or osteoclastic disease, such as septic, infectious or ischemic disease affecting physiological bone structure that has caused the bone to be diseased, prior to inclusion in this study
•Is unable or unwilling to be examined by dermatologists or to undergo laboratory/other diagnostic evaluations should development of NSF be suspected.
•Has received any GBCA other than the one under evaluation at any time prior to inclusion in this study (e.g., a MULTIHANCE subject should not receive any other GBCA including PROHANCE)
•SUBJECTS WITH NO EXPOSURE TO GBCA
•Has received any GBCA at any time prior to inclusion in this study
•Has ever been suspected of, or diagnosed with, NSF prior to the enrollment
•Has been suspected or diagnosed with bone cancer or any other osteoblastic or osteoclastic disease, such as septic, infectious or ischemic disease affecting physiological bone structure that has caused the bone to be diseased prior to inclusion in this study