Gadolinium RetentionNCT03108378
Evaluation of Gd Retention in Human Bone and Skin After MultiHance or ProHance Administration Compared With Control
An observational study of Gadolinium Retention, run by Bracco Diagnostics, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gadolinium Retention
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects scheduled to have hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Official title: A Prospective Multicenter Cohort Study Evaluating the 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
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).
Read the detailed description
Each subject enrolled will already be scheduled to undergo a hip, shoulder or knee replacement, limb amputations or other orthopedic surgical procedures and each subject enrolled in the non-control group will have retrospectively undergone one or more administrations of MultiHance or PROHANCE with the last dose administered at least 1 month before their scheduled surgery. In order to classify the subjects' renal status, the serum creatinine (SCr) value and/or estimated glomerular filtration rate (eGFR) at the time of last MRI with MultiHance or ProHance must be available and collected. The control subjects' documented SCr values will be collected prior to enrollment in the study.
The bone and skin tissue sample(s) collected (during the subjects surgery) will be blinded to gadolinium based contrast agent (GBCA) exposure and sent to a central laboratory where they will be tested for gadolinium (Gd) and other analytes including calcium, phosphorous, sodium, iron, zinc, and potassium. The Gd deposition of the resected bone and skin tissue will be analyzed by Inductively Coupled Plasma Mass Spectroscopy (ICP-MS). The bone and skin tissue will also be analyzed for other analytes using ICP-MS. These sample(s) will be stored at the central laboratory.
A separate sample of the skin tissue collected (during the subjects' surgery) will also be sent to a central dermatopathologist who will be blinded to GBCA exposure and test for any possible NSF related abnormalities. These skin tissue sample(s) will be stored with the central dermatopathology laboratory.
- Conditions
- Gadolinium Retention
- Being tested
- Surgery
- Keywords
- Gadolinium, Bone, Skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
| Study group | Role | What they receive |
|---|---|---|
| MultiHance Single Dose | Subjects who received a single dose of MultiHance and no other Gd agent and who are also scheduled for orthopedic surgery Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: Surgery | |
| Control Subgroup | Subjects who have not received any Gd agent and who are also scheduled for orthopedic surgery Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At any time, due to no GBCA exposure, assessed up to a total of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study startOct 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gadolinium RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gianpaolo Pirovano, MD, Study director, Bracco Diagnostics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108378
- Sponsor's protocol ID
- GMRA-102
- Status last verified
- Aug 2020
- First submitted
- 22 Feb 2017
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Cohort Study Evaluating the 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
- ClinicalTrials.gov ID
- NCT03108378
- Acronym / sponsor ID
- GMRA-102
- Conditions
- Gadolinium Retention
- Keywords
- Gadolinium, Bone, Skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Each subject enrolled will already be scheduled to undergo a hip, shoulder or knee replacement, limb amputations or other orthopedic surgical procedures and each subject enrolled in the non-control group will have retrospectively undergone one or more administrations of MultiHance or PROHANCE with the last dose administered at least 1 month before their scheduled surgery. In order to classify the subjects' renal status, the serum creatinine (SCr) value and/or estimated glomerular filtration rate (eGFR) at the time of last MRI with MultiHance or ProHance must be available and collected. The control subjects' documented SCr values will be collected prior to enrollment in the study.
The bone and skin tissue sample(s) collected (during the subjects surgery) will be blinded to gadolinium based contrast agent (GBCA) exposure and sent to a central laboratory where they will be tested for gadolinium (Gd) and other analytes including calcium, phosphorous, sodium, iron, zinc, and potassium. The Gd deposition of the resected bone and skin tissue will be analyzed by Inductively Coupled Plasma Mass Spectroscopy (ICP-MS). The bone and skin tissue will also be analyzed for other analytes using ICP-MS. These sample(s) will be stored at the central laboratory.
A separate sample of the skin tissue collected (during the subjects' surgery) will also be sent to a central dermatopathologist who will be blinded to GBCA exposure and test for any possible NSF related abnormalities. These skin tissue sample(s) will be stored with the central dermatopathology laboratory.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MultiHance Single Dose | – | Procedure: SurgerySubjects who received a single dose of MultiHance and no other Gd agent and who are also scheduled for orthopedic surgery |
| MultiHance Multiple Dose | – | Procedure: SurgerySubjects who received multiple doses of MultiHance and no other Gd agent and who are also scheduled for orthopedic surgery |
| ProHance Single Dose | – | Procedure: SurgerySubjects who received a single dose of ProHance and no other Gd agent and who are also scheduled for orthopedic surgery |
| ProHance Multiple Dose | – | Procedure: SurgerySubjects who received multiple doses of ProHance and no other Gd agent and who are also scheduled for orthopedic surgery |
| Control Subgroup | – | Procedure: SurgerySubjects who have not received any Gd agent and who are also scheduled for orthopedic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects scheduled to have hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgeryhip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures | Procedure or surgery | Control Subgroup, MultiHance Multiple Dose, MultiHance Single Dose, ProHance Multiple Dose, ProHance Single Dose |
Primary outcome
Gadolinium deposition in bone and skin for non-control group
Time frame: At least one month from exposure to GBCA, assessed up to a total of 36 months
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.
Gadolinium deposition in bone and skin for control group
Time frame: At any time, due to no GBCA exposure, assessed up to a total of 36 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Gadolinium Retention
RecruitingPhase 4
Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
Motor Function, Cognitive Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianpaolo Pirovano, MD study director
Bracco Diagnostics, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gadolinium Retention, run by Bracco Diagnostics, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gadolinium deposition in bone and skin for non-control group (time frame: At least one month from exposure to GBCA, assessed up to a total of 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.