Gadolinium ToxicityNCT02512796
In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes
An observational study of Gadolinium Toxicity, run by University of Virginia at 1 site in United States.
Trial summary
Gadolinium contrast agents are frequently administered for MRI imaging. Very little is known of its toxicity outside of patients with reduced renal function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gadolinium Toxicity
- What is being tested?
- Gadolinium contrast dye
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 2017
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Gadolinium exposed patients. We will use age- and sex-matched controls with and without organ transplants and not exposed to gadolinium contrast agents (within the last 3 years) as controls.
Who may be able to join
- Renal, pancreas or liver transplant OR those without organ transplant OR controls
- Age 18-70
- Both gender
- Exposure to gadolinium contrast agents (no exposure in controls)
- Have had a transplant, have had a contrast dye with an MRI
- Have not had a transplant and have had a contrast dye with an MRI
- Healthy person who has not had an MRI or gadolinium for any other reason.
Who cannot join
- End stage kidney disease or Stage 5
- Previous diagnosis of Nephrogenic Systemic Fibrosis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
About this study
Gadolinium contrast agents are frequently administered for MRI imaging. Very little is known of its toxicity outside of patients with reduced renal function.
Read the detailed description
Gadolinium contrast is administered to patients during MRI imaging. Recently, the investigators have observed potential gadolinium toxicity in some patients. To investigate this, the investigators propose to collect clinical data and lab data obtained as a part of clinical care. The investigators also plan to obtain 25 cc of peripheral blood at 2-4 weeks, 4-6 weeks and again at 3 months to identify unique monocyte signatures, gene polymorphisms, and to quantitate circulating fibrocytes (in fresh blood and after culture). Plan to enroll 15 patients with kidney, pancreas or liver transplant and exposed to gadolinium contrast agents, 15 non-transplant patients exposed to gadolinium contrast and 30 age- and sex-matched healthy controls not exposed to gadolinium contrast.
- Conditions
- Gadolinium Toxicity
- Being tested
- Gadolinium contrast dye
- Keywords
- Liver transplantation, Renal transplantation, Pancreas transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadolinium contrast dyeDrug
Gadolinium contrast dye administered during MRI
| Study group | Role | What they receive |
|---|---|---|
| Transplant patients, MRI with Gadolinium contrast dye | Patients with kidney, pancreas or liver transplant and exposed to gadolinium contrast agents. Receives: Drug: Gadolinium contrast dye | |
| Non-transplant patients, MRI with Gadolinium contrast dye | Non-transplant patients exposed to gadolinium contrast. Receives: Drug: Gadolinium contrast dye | |
| Healthy controls, no transplant no Gadolinium contrast dye | Age- and sex-matched healthy controls not exposed to gadolinium contrast. |
What is being measured
The primary outcome is the main question the study is designed to answer.
total number of circulating fibrocytes
2-4 weeks after gadolinium contrast exposure
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gadolinium ToxicityStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sundararaman Swaminathan, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512796
- Sponsor's protocol ID
- 18302
- Status last verified
- Jul 2015
- First submitted
- 27 Jul 2015
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes
- ClinicalTrials.gov ID
- NCT02512796
- Acronym / sponsor ID
- 18302
- Conditions
- Gadolinium Toxicity
- Keywords
- Liver transplantation, Renal transplantation, Pancreas transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 31 Jul 2015 (estimated)
- 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.
Gadolinium contrast agents are frequently administered for MRI imaging. Very little is known of its toxicity outside of patients with reduced renal function.
Detailed description
Gadolinium contrast is administered to patients during MRI imaging. Recently, the investigators have observed potential gadolinium toxicity in some patients. To investigate this, the investigators propose to collect clinical data and lab data obtained as a part of clinical care. The investigators also plan to obtain 25 cc of peripheral blood at 2-4 weeks, 4-6 weeks and again at 3 months to identify unique monocyte signatures, gene polymorphisms, and to quantitate circulating fibrocytes (in fresh blood and after culture). Plan to enroll 15 patients with kidney, pancreas or liver transplant and exposed to gadolinium contrast agents, 15 non-transplant patients exposed to gadolinium contrast and 30 age- and sex-matched healthy controls not exposed to gadolinium contrast.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transplant patients, MRI with Gadolinium contrast dye | – | Drug: Gadolinium contrast dyePatients with kidney, pancreas or liver transplant and exposed to gadolinium contrast agents. |
| Non-transplant patients, MRI with Gadolinium contrast dye | – | Drug: Gadolinium contrast dyeNon-transplant patients exposed to gadolinium contrast. |
| Healthy controls, no transplant no Gadolinium contrast dye | – | –Age- and sex-matched healthy controls not exposed to gadolinium contrast. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Gadolinium exposed patients. We will use age- and sex-matched controls with and without organ transplants and not exposed to gadolinium contrast agents (within the last 3 years) as controls.
Key inclusion criteria (7 listed)
- Renal, pancreas or liver transplant OR those without organ transplant OR controls
- Age 18-70
- Both gender
- Exposure to gadolinium contrast agents (no exposure in controls)
- Have had a transplant, have had a contrast dye with an MRI
Key exclusion criteria (2 listed)
- End stage kidney disease or Stage 5
- Previous diagnosis of Nephrogenic Systemic Fibrosis
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 |
|---|---|---|
| Gadolinium contrast dyeGadolinium contrast dye administered during MRI | Drug | Non-transplant patients, MRI with Gadolinium contrast dye, Transplant patients, MRI with Gadolinium contrast dye |
Primary outcome
total number of circulating fibrocytes
Time frame: 2-4 weeks
2-4 weeks after gadolinium contrast exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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.
Sundararaman Swaminathan, MD principal investigator
University of Virginia
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 Toxicity, run by University of Virginia 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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Jul 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sundararaman Swaminathan, MD (434-982-3577, ss4sa@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total number of circulating fibrocytes (time frame: 2-4 weeks). 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 31 Jul 2015.