RecruitingNCT06269055
Long-term Result of DTPA (Diethylenetriamine Pentaacetate) Chelation for Gadolinium Deposition Disease
Long-term Result of DTPA Chelation for Gadolinium Deposition Disease
Sponsor
Stanford University
Enrollment
50 participants
Start Date
Dec 2, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
This study is aimed at describing the degree of benefit, if any, and the adverse effects, if any, from receiving 5 or more treatment sessions of Gadolinium Deposition Disease using two-day chelation treatment with the chelating agents Calcium Diethylenetriamine pentaacetate (Ca-DTPA) and Zinc Diethylenetriamine pentaacetate (Zn-DTPA).
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Age 18 or older,
- 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;
- has had five or more 2-day chelation treatments with Ca-DTPA/Zn-DTPA;
- will be at least 2 weeks post the last chelation treatment at the time of completing the patient data-gathering questionnaires.
- no more than 2 years have elapsed since the last DTPA chelation.
Exclusion Criteria2
- \. 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.
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Interventions
OTHERInterview
Telephone interview and questionnaires about the results and side effects experienced
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06269055