Evaluation of Gd Retention in Human Bone and Skin After MultiHance or ProHance Administration Compared With Control

NCT03108378 | Completed

• 1 other identifier: GMRA-102
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects must be scheduled to undergo an orthopedic surgical procedure. Subjects in the non-control group must have previously received an MRI with MultiHance or ProHance with at least 1 month between the last administration and the scheduled surgery. Subjects who have never received MultiHance or ProHance or any other gadolinium agent will also be enrolled. Subjects must have a test of their kidney function (SCr) at the time of the last MRI examination or at the time of enrollment if they never received gadolinium. A sample of bone and skin will be collected from the scheduled surgery and tested for the amount of gadolinium. An additional sample of skin will be collected for testing the presence of nephrogenic systemic fibrosis (NSF).

Conditions

Gadolinium Retention

Keywords

Gadolinium; Bone; Skin

Outcome Measures

Primary Outcomes (2)

• Gadolinium deposition in bone and skin for non-control group

  Determine the long-term gadolinium deposition in bone tissue and skin in subjects undergoing orthopedic surgery using Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) in nmol gadolinium/g from surgically removed bone and skin.

  At least one month from exposure to GBCA, assessed up to a total of 36 months

• Gadolinium deposition in bone and skin for control group

  Determine the long-term gadolinium deposition in bone tissue and skin in subjects undergoing orthopedic surgery using Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) in nmol gadolinium/g from surgically removed bone and skin.

  At any time, due to no GBCA exposure, assessed up to a total of 36 months

Study Arms (5)

MultiHance Single Dose

Subjects who received a single dose of MultiHance and no other Gd agent and who are also scheduled for orthopedic surgery

Procedure: Surgery

MultiHance Multiple Dose

Subjects who received multiple doses of MultiHance and no other Gd agent and who are also scheduled for orthopedic surgery

Procedure: Surgery

ProHance Single Dose

Subjects who received a single dose of ProHance and no other Gd agent and who are also scheduled for orthopedic surgery

Procedure: Surgery

ProHance Multiple Dose

Subjects who received multiple doses of ProHance and no other Gd agent and who are also scheduled for orthopedic surgery

Procedure: Surgery

Control Subgroup

Subjects who have not received any Gd agent and who are also scheduled for orthopedic surgery

Procedure: Surgery

Interventions

Surgery PROCEDURE

hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures

Control Subgroup; MultiHance Multiple Dose; MultiHance Single Dose; ProHance Multiple Dose; ProHance Single Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects scheduled to have hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures

You may qualify if:

• 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

You may not qualify if:

• 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
• Is unable or unwilling to be examined by dermatologists or to undergo laboratory/other diagnostic evaluations should development of NSF be suspected.
• SUBJECTS WITH NO EXPOSURE TO GBCA:
• Has ever been suspected of, or diagnosed with, NSF prior to the enrollment
• Is unable or unwilling to be examined by dermatologists or to undergo laboratory/other diagnostic evaluations should development of NSF be suspected.

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone \& Skin Tissue

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Gianpaolo Pirovano, MD

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: April 11, 2017
• Study Start: October 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)