DTPA Chelation for Gadolinium Deposition Disease

Overseen By Meredith Barad, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Stanford University

Must not be taking: Lithium, NSAIDs, SSRIs, others

Disqualifiers: Autoimmune disorders, Cancer, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special injection to remove harmful gadolinium from patients who have symptoms after an MRI. The treatment works by binding to the gadolinium and helping the body expel it. Gadolinium-based contrast agents have been used for over three decades in MRI to improve image contrast, but they can deposit in organs such as bone.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications that lower specific cytokine levels, such as lithium, n-acetylcysteine, aspirin, NSAIDs, sertraline, and other similar antidepressants, as well as some supplements like ashwagandha, astaxanthin, and milk thistle.

Is DTPA chelation safe for humans?

DTPA chelation, including Calcium DTPA and Zinc DTPA, has been used in humans and is generally considered safe. Studies have shown that adverse reactions are mild and occur in a small percentage of patients, with no severe reactions or deaths reported. ^{1 2 3 4 5}

How does the drug DTPA Chelation for Gadolinium Deposition Disease differ from other treatments?

DTPA Chelation using Calcium DTPA and Zinc DTPA is unique because it involves intravenous administration of chelating agents that bind to gadolinium, a toxic metal, to help remove it from the body. This approach is different from other treatments as it directly targets the removal of gadolinium, which is not typically addressed by standard therapies for gadolinium deposition disease. ^{3 5 6 7 8}

What data supports the effectiveness of the drug Calcium DTPA and Zinc DTPA for treating Gadolinium Deposition Disease?

The research suggests that DTPA is effective in treating Gadolinium Deposition Disease because it has a high affinity for binding gadolinium, which helps remove the metal from the body. This is supported by clinical experience and expert opinion indicating that DTPA is the most effective chelating agent for this condition. ^{3 6 7 9 10}

Who Is on the Research Team?

Lorrin M Koran, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Have had an MRI with contrast at least 3 months and less than 3 years before study enrollment.

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.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six paired Calcium-DTPA/Zinc-DTPA chelation treatments to remove gadolinium

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Calcium DTPA and Zinc DTPA

Trial Overview 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.

How Is the Trial Designed?

Group I: Chelation with open-label Ca-DTPA and Zn-DTPA Experimental Treatment 1 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 University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Gd-DTPA, a contrast agent used in MRI, has a very low incidence of adverse drug reactions (ADRs) at only 1.46% in a study of 13,439 patients, which is even lower than that of iodinated contrast media.

The safety profile of Gd-DTPA is favorable, showing good renal tolerance even in patients with pre-existing renal impairment, and fast bolus injections were well tolerated without additional risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerance data of Gd-DTPA: a review. Niendorf, HP., Dinger, JC., Haustein, J., et al.[2022]

In a study involving 2,102 adult patients, gadodiamide injection was found to be safe at a dose of 0.1 mmol/kg, with only 4.4% experiencing adverse events, primarily mild discomfort at the injection site.

No severe adverse events or deaths were reported, indicating that gadodiamide is a well-tolerated non-ionic contrast agent for MR imaging of the central nervous system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical evaluation of the tolerability of gadodiamide, a new nonionic contrast agent in MRI of the central nervous system]. Aslanian, V., Lemaignen, H., Bunouf, P., et al.[2014]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Intravenous Calcium-/Zinc-Diethylene Triamine Penta-Acetic Acid in Patients With Presumed Gadolinium Deposition Disease: A Preliminary Report on 25 Patients. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Dynamic Serial Cytokine Measurements During Intravenous Ca-DTPA Chelation in Gadolinium Deposition Disease and Gadolinium Storage Condition: A Pilot Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Severity of Flare Reactions in Diethylenetriamine Pentaacetate Chelations: Report on Different Immune Dampening Strategies in Clinical Practice. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Gadolinium contrast agents - are they really safe? [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Gadolinium Deposition Disease: Current State of Knowledge and Expert Opinion. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Tolerance data of Gd-DTPA: a review. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Clinical evaluation of the tolerability of gadodiamide, a new nonionic contrast agent in MRI of the central nervous system]. [2014]

8. France pubmed.ncbi.nlm.nih.gov

[Comparative studies of the tolerability of gadodiamide, dimeglumine gadopentetate and meglumine gadoterate in MRI tests of the central nervous system]. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Clinical and biological consequences of transmetallation induced by contrast agents for magnetic resonance imaging: a review. [2015]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The use of a binary chelate formulation: Could gadolinium based linear contrast agents be rescued by the addition of zinc selective chelates? [2019]