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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 below
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My urine test shows high levels of gadolinium 30 days after my MRI.
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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 weeks
Treatment ~ Varies
Follow Up ~2 days before first dtpa treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days before first dtpa treatment for reporting.

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 more

Trial 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
2,386 Previous Clinical Trials
17,334,002 Total Patients Enrolled
1 Trials studying Gadolinium Deposition Disease
50 Patients Enrolled for Gadolinium Deposition Disease
Lorrin M Koran, MDPrincipal InvestigatorStanford University

Media Library

Calcium DTPA and Zinc DTPA (Chelating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05359835 — Phase < 1
Gadolinium Deposition Disease Research Study Groups: Chelation with open-label Ca-DTPA and Zn-DTPA
Gadolinium Deposition Disease Clinical Trial 2023: Calcium DTPA and Zinc DTPA Highlights & Side Effects. Trial Name: NCT05359835 — Phase < 1
Calcium DTPA and Zinc DTPA (Chelating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05359835 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility for participants in this study restricted to those under 45 years old?

"The inclusion criteria for this medical study mandate that all participants be of legal age and under the age of 65."

Answered by AI

What is the current enrollment quota for this experiment?

"Affirmative, clinicaltrials.gov has data which suggests this investigation is actively recruiting participants. It was first made public on April 11th 2023 and most recently updated on the 10th of the same month. The trial seeks out 6 subjects from 1 site in particular."

Answered by AI

Are there any ongoing opportunities to participate in this experiment?

"The details posted on clinicaltrials.gov confirm that this medical experiment is currently open for recruitment and has been since April 11th, 2023. It was last modified a day prior to its original post date of April 10th, 2023."

Answered by AI

What is the goal of this experiment?

"Within the 2 day period prior to DTPA treatment, this trial's primary purpose is to assess the 0-10 Scale of Pain Severity. Further objectives include evaluating Cognitive Function - Short Form 8a (Promis Item Bank v2.0), Gadolinium Deposition Disease Symptom rating scale, and short form 8a (Promis)."

Answered by AI

Is there eligibility criteria I must meet in order to participate in this clinical experiment?

"This medical trial is seeking six adults aged 18 to 65 who are currently living with gadolinium deposition disease and can provide informed consent. Additional requirements include having an MRI with contrast within the last 6 years and a 24-hour urine analysis that documents abnormally high levels of gadolinium excretion, as well as any cognitive disturbance, extremity pain, frequent headaches, chest wall pain, skin induration/hyperpigmentation/pain or h. arthralgia they may be experiencing."

Answered by AI

Who else is applying?

What site did they apply to?
Stanford University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I am pretty sure I have Gadolinium Deposition Disease, and am desperately seeking help. Thank you.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
DTPA (Diethylenetriaminepenta-acetate) Chelation for Symptoms After Gadolinium-assisted MRI Exposure
Lorrin M Koran, MD 2023. "DTPA (Diethylenetriaminepenta-acetate) Chelation for Symptoms After Gadolinium-assisted MRI Exposure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05359835.
~4 spots leftby Nov 2025
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