Stanford University Medical Center
Stanford, California, 94305, United States
NCT Number: NCT06269055
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).
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Notify Me18 year and older
All sexes
Observational
Stanford, California, 94305, United States
Potential participants will be invited to contact Dr. Koran by email to receive a telephone screening Informed Consent. Those who provide informed consent will have their questions about the study answered and their interest and eligibility assessed via telephone interview. Those who wish to participate will be sent an Informed Consent for study participation. Those who return the consent will be sent four study questionnaires for completion and return. The returned forms will be reviewed by Dr. Koran or his co-investigator, and a follow-up phone call will be offered via Secure Stanford email. The phone call will involve answering any new questions the participant has, and clarifying the participant's responses to the data collection forms if clarification is needed. Participants who wish to receive a summary of the study's results once it is completed and accepted for publication, will be emailed a summary via Secure Stanford email.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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Telephone interview and questionnaires about the results and side effects experienced
Other names: Telephone interview and written questionnaire completion
Time frame: Two or more weeks after the last of 5 of more DTPA chelation treatments
Patient-completed data regarding symptoms experienced and their intensity when they began and currently, rated from 0 (none) to 5 (very severe). Outcome measure will be change in each symptom's intensity.
Time frame: Past 7 days
An 8-item patient rated questionnaire with ratings of cognitive symptoms from Very Often to Never for each item, rated 5 (Never) to 1 (Very often). Higher scores indicate better cognitive function.
Time frame: Past week
A brief, patient-rated measure of disability and impairment in Work/School, Social Life, and Family Life/Home Responsibilities. Each area is rated from 0 (no disability) to 10 (extreme disability). Higher scores indicate greater disability in the life area rated.
Time frame: Onset on the day of or within one day of DTPA chelation
Checklist form regarding possible side effects of DTPA chelation
Stanford University
Other
Long-term Result of DTPA Chelation for Gadolinium Deposition Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.