Long-term effects of DTPA chelation for Gadolinium Deposition Disease
Long-term Result of DTPA Chelation for Gadolinium Deposition Disease
This study is testing if a special treatment called chelation therapy can help people with Gadolinium Deposition Disease feel better over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT06269055 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term benefits and potential adverse effects of chelation therapy using Calcium Diethylenetriamine pentaacetate (Ca-DTPA) and Zinc Diethylenetriamine pentaacetate (Zn-DTPA) in patients diagnosed with Gadolinium Deposition Disease. Participants will undergo a telephone screening process to assess their eligibility and provide informed consent. Following consent, they will complete questionnaires regarding their symptoms and treatment history, which will be reviewed by the research team. A follow-up call will be conducted to clarify responses and answer any questions about the study.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older who have been diagnosed with Gadolinium Deposition Disease and have undergone five or more chelation treatments.
Not a fit: Patients who are not fluent in English or have significant communication impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of DTPA chelation therapy for alleviating symptoms associated with Gadolinium Deposition Disease.
How similar studies have performed: While there is limited data on the long-term effects of DTPA chelation specifically for Gadolinium Deposition Disease, similar chelation therapies have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 or older, 2. Diagnosis of Gadolinium Deposition Disease (GDD) established by treating MD according to current criteria and confirmed by investigator review of screening questionnaire (dx criteria: presence of at least 3 of 8 symptoms-cognitive disturbance, extremity pain, arthralgia, chest wall pain, skin pain, headache, skin induration, and skin hyperpigmentation; and, had an unprovoked 24-hour Gd urine excretion level exceeding the laboratory norm at least 28 days after the symptom-inducing MRI; 3. has had five or more 2-day chelation treatments with Ca-DTPA/Zn-DTPA; 4. will be at least 2 weeks post the last chelation treatment at the time of completing the patient data-gathering questionnaires. 5. no more than 2 years have elapsed since the last DTPA chelation. Exclusion Criteria: 1\. Not fluent in written and spoken English; 2. having impaired hearing that significantly decreases the person's ability to communicate via telephone; 3. Prisoners; 4. Unable to provide informed consent; 5. Participating or having participated in protocols involving a pharmacological treatment of GDD other than DTPA chelation. Note: brief pre- or post-DTPA chelation to prevent GDD symptom flare is not an exclusion criterion. \-
Where this trial is running
Stanford, California
- Stanford University Medical Center — Stanford, California, United States (Recruiting)
Study contacts
- Study coordinator: Lorrin M Koran, MD
- Email: lkoran@stanford.edu
- Phone: 650 321-6804
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.