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Completed
NCT06269055
Long-term Result of DTPA (Diethylenetriamine Pentaacetate) Chelation for Gadolinium Deposition Disease
Conditions: Gadolinium Deposition Disease, Ca-DTPA
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 30
Sponsor: Stanford University
Location: Stanford University Medical Center Stanford California
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 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.
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Source: ClinicalTrials.gov (NCT06269055). StuddyBuddy aggregates publicly available trial information.