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Chelating Agent
DTPA Chelation for Gadolinium Deposition Disease
Phase < 1
Waitlist Available
Led By Lorrin M Koran, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a 24-hour urine analysis 30 days or more post-MRI that documents abnormally high levels of gadolinium excretion.
Exhibit within 30 days of the contrast-assisted MRI new onset of 3 or more of the following symptoms: cognitive disturbance, extremity pain, frequent headaches, chest wall pain, skin induration, skin hyper-pigmentation, skin pain, arthralgia.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days before first 2-day dtpa chelation
Awards & highlights
Study Summary
This trial will study the effects of drugs that may reduce symptoms of Gadolinium Deposition Disease caused by retained gadolinium from MRI contrast agents. It will measure symptom relief & cytokines before & after treatment.
Who is the study for?
This trial is for adults aged 18-65 who've had an MRI with gadolinium contrast and show symptoms of Gadolinium Deposition Disease. Participants must have high urine gadolinium levels post-MRI and at least three new symptoms like pain or cognitive issues. Excluded are those with autoimmune diseases, pregnant women, prior chelation treatment recipients, or individuals with conditions that mimic GDD symptoms.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of intravenous Ca-DTPA/Zn-DTPA in removing retained gadolinium from patients' bodies after MRI exposure. It involves up to six chelation treatments and measures symptom relief as well as blood cytokine levels before and after therapy.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include local reactions at the injection site, changes in mineral levels due to chelation therapy (like calcium or zinc), nausea, fever, headache, or low blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My urine test shows high levels of gadolinium 30 days after my MRI.
Select...
I have experienced new symptoms like memory issues, pain, or skin changes recently.
Select...
I have only received Gadobutrol (Gadovist) as an MRI contrast agent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 days before first dtpa treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 days before first dtpa treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
0-10 Scale of Pain Severity
0-10 Scale of Pain Severity (Higher is more severe pain)
Secondary outcome measures
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Cognitive Function - Short Form 8a (Promis Item Bank v2.0) (Higher score = more cognitive complaint)
Gadolinium Deposition Disease Symptom rating scale
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Chelation with open-label Ca-DTPA and Zn-DTPAExperimental Treatment1 Intervention
Six chelation treatments utilizing Ca-DTPA on day 1 and Zn-DTPA on day 2. Paired, 2-chelation day treatments will take place at intervals of one week or more.
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,406 Previous Clinical Trials
17,343,139 Total Patients Enrolled
1 Trials studying Gadolinium Deposition Disease
50 Patients Enrolled for Gadolinium Deposition Disease
Lorrin M Koran, MDPrincipal InvestigatorStanford University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My symptoms could be due to my current health conditions and medications.I do not have Wilson's Disease, hemochromatosis, cancer (except for non-melanoma skin cancer), impaired kidney function, or heart disease affecting my heart's function.I have a condition like diabetes or depression that affects my immune system.I have been diagnosed with an autoimmune disorder like lupus, rheumatoid arthritis, or scleroderma.I am between 18 and 65 years old and can make my own medical decisions.My urine test shows high levels of gadolinium 30 days after my MRI.I have experienced new symptoms like memory issues, pain, or skin changes recently.I have only received Gadobutrol (Gadovist) as an MRI contrast agent.You are currently involved in another study that involves treatment for GDD.I have received chelation therapy for Gadolinium Deposition Disease.My doctor diagnosed me with a condition that could cause symptoms of GDD.I cannot or will not stop taking certain medications or supplements that affect cytokine levels.I am on medication that could cause symptoms of GDD.
Research Study Groups:
This trial has the following groups:- Group 1: Chelation with open-label Ca-DTPA and Zn-DTPA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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