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 个研究点目标入组 36 人开始时间: 2013年2月26日最近更新: 2018年10月22日

适应症

试验速览

暂无简介。

•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
•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
•Has prior SCr and/or eGFR at time of enrollment
•Is =18 years of age
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 24

•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
•Is unable or unwilling to be examined by dermatologists or to undergo laboratory/other diagnostic evaluations should development of NSF be suspected.

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