What side effects are associated with this type of intervention?

Chelation therapy using Ca-DTPA/Zn-DTPA for Gadolinium Deposition Disease aims to remove retained gadolinium from the body. Common side effects of chelation therapy can include nausea, vomiting, diarrhea, headache, fatigue, and injection site reactions. In some cases, more severe side effects such as electrolyte imbalances, kidney dysfunction, and allergic reactions may occur. It is important for patients to discuss potential risks and benefits with their healthcare provider.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Gadolinium Deposition Disease (GDD). However, chelation therapy using agents like Ca-DTPA and Zn-DTPA is being studied for its potential to remove gadolinium from the body. These agents work by binding to gadolinium, allowing it to be excreted from the body, and are currently under investigation for their safety and effectiveness in patients with GDD.

What other types of research exist?

Currently, there are no specific novel alternatives to Ca-DTPA/Zn-DTPA chelation therapy for Gadolinium Deposition Disease mentioned in the provided context. The focus remains on the safety and effectiveness of Ca-DTPA/Zn-DTPA. Patients should consult their healthcare provider for the most up-to-date treatment options.

← Back to Search

Chelating Agent

DTPA Chelation for Gadolinium Deposition Disease

Q: What is the mechanism of action of this treatment?

Chelation therapy, specifically using Ca-DTPA (Calcium Diethylenetriaminepenta-acetate) and Zn-DTPA (Zinc Diethylenetriaminepenta-acetate), works by binding to gadolinium ions retained in the body after MRI procedures that use gadolinium-based contrast agents. This binding forms a stable complex that can be excreted from the body, thereby reducing the toxic effects of gadolinium accumulation. For patients with Gadolinium Deposition Disease, this is crucial as it helps alleviate symptoms associated with gadolinium retention, such as pain, cognitive disturbances, and skin changes, by effectively removing the heavy metal from their system.

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.

Must not have

Diagnosed by the patient's treating MD with an autoimmune or rheumatological disorder such as systemic lupus, rheumatoid arthritis or scleroderma;

taking a medication or medications that could cause 3 or more of the 8 diagnostic symptoms of GDD;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 days before first 2-day dtpa chelation

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with an autoimmune disorder like lupus, rheumatoid arthritis, or scleroderma.

Select...

I am on medication that could cause symptoms of GDD.

Select...

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.

Select...

I cannot or will not stop taking certain medications or supplements that affect cytokine levels.

Select...

I have received chelation therapy for Gadolinium Deposition Disease.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days before first dtpa treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

0-10 Scale of Pain Severity

0-10 Scale of Pain Severity (Higher is more severe pain)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chelation therapy, specifically using Ca-DTPA (Calcium Diethylenetriaminepenta-acetate) and Zn-DTPA (Zinc Diethylenetriaminepenta-acetate), works by binding to gadolinium ions retained in the body after MRI procedures that use gadolinium-based contrast agents. This binding forms a stable complex that can be excreted from the body, thereby reducing the toxic effects of gadolinium accumulation. For patients with Gadolinium Deposition Disease, this is crucial as it helps alleviate symptoms associated with gadolinium retention, such as pain, cognitive disturbances, and skin changes, by effectively removing the heavy metal from their system.

Case Report: Clinical Outcome From Pallidal Stimulation in a Patient With Levodopa-Resistant Dopa-Responsive Dystonia.Focused ultrasound and other lesioning in the treatment of tremor.Deep brain stimulation and stereotactic-assisted brain graft injection targeting fronto-striatal circuits for Huntington's disease: an update.