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

NCT ID: NCT06269055

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2026-05-31

Brief 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).

Detailed Description

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.

Conditions

Gadolinium Deposition Disease; Ca-DTPA

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Interview

Telephone interview and questionnaires about the results and side effects experienced

Intervention Type: OTHER

Other Intervention Names

Telephone interview and written questionnaire completion

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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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Lorrin M Koran, MD

Professor of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University Medical Center

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lorrin M Koran, MD

Role: CONTACT

lkoran@stanford.edu

650 321-6804

Jarrod Ehrie, MD

Role: CONTACT

ehrie@stanford.ecu

Facility Contacts

Lorrin Koran, M.D.

Role: primary

lkoran@stanford.edu

650 799-1647

References

Semelka RC, Ramalho M. Gadolinium Deposition Disease: Current State of Knowledge and Expert Opinion. Invest Radiol. 2023 Aug 1;58(8):523-529. doi: 10.1097/RLI.0000000000000977. Epub 2023 Apr 11.

Reference Type: BACKGROUND

PMID: 37058336 (View on PubMed)

Other Identifiers

73151

Identifier Type: -

Identifier Source: org_study_id