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Completed

NCT Number: NCT06269055

Long-term Result of DTPA (Diethylenetriamine Pentaacetate) Chelation for Gadolinium Deposition Disease

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University Medical Center

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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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Treatment and study plan

interview

Other

Telephone interview and questionnaires about the results and side effects experienced

Other names: Telephone interview and written questionnaire completion

Primary outcomes

  1. Rating of Gadolinium Deposition Disease Symptoms at start of GDD and currently

    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.

Secondary outcomes

  1. PROMIS Item Bank v2.0 - Cognitive Function- Short Form 8a

    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.

  2. Sheehan Disability Scale

    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.

Other outcomes

  1. DTPA-chelation side effects form

    Time frame: Onset on the day of or within one day of DTPA chelation

    Checklist form regarding possible side effects of DTPA chelation

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Long-term Result of DTPA Chelation for Gadolinium Deposition Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.