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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of two drugs, Calcium DTPA and Zinc DTPA (both chelating agents), in removing gadolinium, a heavy metal, from individuals with Gadolinium Deposition Disease (GDD). Gadolinium can linger in the body after an MRI with contrast, causing symptoms such as memory issues, joint pain, or skin changes. Participants will receive up to six treatments, and researchers will measure certain proteins in the blood that might be elevated due to retained gadolinium. The trial seeks individuals who had an MRI with contrast using Gadobutrol (Gadovist) 3 months to 3 years ago and have experienced at least three specific symptoms, like frequent headaches or skin pain, since then. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering a unique opportunity to contribute to groundbreaking medical advancements.

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 there any evidence suggesting that the treatment with Calcium DTPA and Zinc DTPA is likely to be safe for humans?

Research has shown that Calcium DTPA and Zinc DTPA are generally safe for chelation therapy. Chelation involves these drugs removing heavy metals from the body. Studies have found that most people tolerate these treatments well without serious side effects. However, caution is advised for individuals with kidney problems, as these drugs exit the body through urine. Overall, despite some considerations, the treatments maintain a good safety record. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Gadolinium Deposition Disease, which primarily focus on symptom management, Calcium DTPA and Zinc DTPA chelation therapies aim to directly remove gadolinium from the body. These treatments use chelation, a process where the DTPA compounds bind to gadolinium, allowing it to be excreted from the body. Researchers are excited because this approach targets the root cause of gadolinium retention, potentially offering more effective relief from symptoms and reducing long-term health risks associated with gadolinium exposure.

What evidence suggests that this treatment might be an effective treatment for Gadolinium Deposition Disease?

Research has shown that DTPA chelation therapy can help with Gadolinium Deposition Disease. In this trial, participants will receive treatments with Calcium DTPA and Zinc DTPA. Studies have found that these treatments significantly increase the amount of gadolinium removed from the body through urine, helping the body eliminate this heavy metal. Patients have reported feeling moderately better after receiving the therapy. The treatment works because DTPA strongly attaches to gadolinium, aiding in its removal from the body. ^{1 5 6 7 8}

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

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02947022

Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat ... Purpose: There are two goals we have for this prospective single arm study; to see an increase in the amount of gadolinium in 24 hour urine collection ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29419708/

Intravenous Calcium-/Zinc-Diethylene Triamine Penta ... Conclusions: Three courses of intravenous Ca-/Zn-DTPA therapy results in significantly increased urine content of Gd after treatment and moderate symptomatic ...

3. withpower.com withpower.com/trial/early-phase-1-gadolinium-deposition-disease-6-2022-6c593

DTPA Chelation for 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 ...

4. researchgate.net researchgate.net/publication/322996646_Intravenous_Calcium-Zinc-Diethylene_Triamine_Penta-Acetic_Acid_in_Patients_With_Presumed_Gadolinium_Deposition_Disease_A_Preliminary_Report_on_25_Patients

Intravenous Calcium-/Zinc-Diethylene Triamine Penta ... Symptomatic improvement of patients was determined by use of a 10-point scale of patient symptoms. Serum electrolytes were quantified. Results: ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05359835?term=pentetic%20acid&viewType=Table&rank=7

DTPA (Diethylenetriaminepenta-acetate) Chelation for ... The outcome data will include measures of symptom relief after as many as six paired Calcium-DTPA / Zinc-DTPA chelation treatments. The study also aims at ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11306197/

Near-cure in patients with Gadolinium deposition disease ... Subjects with GDD can experience near-cure with IV DTPA chelation. Factors surveyed that predict near-cure include the start of chelation in the first year.

7. vitalityintegrative.com vitalityintegrative.com/gadolinium-toxicity/

Gadolinium Toxicity | Vitality Integrative Gadolinium toxicity refers to a variety of very rare adverse effects associated with the body's exposure to gadolinium, a heavy metal.

8. remm.hhs.gov remm.hhs.gov/dtpa.htm

Ca-DTPA/Zn-DTPA (Diethylentriamene pentaacetate) Since radioactive materials chelated to DTPA are excreted in urine, DTPA must be used carefully in people with diminished renal function. The safety and ...