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

Long-term Result of DTPA 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).

Study Overview

• Status: Recruiting
• Conditions: Gadolinium Deposition Disease; Ca-DTPA
• Intervention / Treatment: Other: Interview

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Lorrin M Koran, MD; Phone Number: 650 321-6804; Email: lkoran@stanford.edu
• Study Contact Backup: Name: Jarrod Ehrie, MD; Email: ehrie@stanford.ecu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University Medical Center
      • Contact: Lorrin Koran, M.D.; Phone Number: 650 799-1647; Email: lkoran@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients in the U.S. who developed Gadolinium Deposition Disease (GDD) within 28 days of undergoing a contrast-assisted MRI, in which the contrast agent contained the metal gadolinium, and who retained enough gadolinium to have abnormally high 24-hour urine levels 28 or more days post MRI. Participants must satisfy the Inclusion/Exclusion criteria noted above.

Description

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.

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rating of Gadolinium Deposition Disease Symptoms at start of GDD and currently	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.	Two or more weeks after the last of 5 of more DTPA chelation treatments

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Item Bank v2.0 - Cognitive Function- Short Form 8a	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.	Past 7 days
Sheehan Disability Scale	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.	Past week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
DTPA-chelation side effects form	Checklist form regarding possible side effects of DTPA chelation	Onset on the day of or within one day of DTPA chelation

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: DTPA, chelation
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic
• Other Study ID Numbers: 73151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No