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

NCT06269055 | Completed

• 1 other identifier: 73151
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Ca-DTPA; Gadolinium Deposition Disease

Keywords

DTPA, chelation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Past 7 days

• Sheehan Disability Scale

  Past week

Other Outcomes (1)

• DTPA-chelation side effects form

  Onset on the day of or within one day of DTPA chelation

Interventions

Interview OTHER

Telephone interview and questionnaires about the results and side effects experienced

Also known as: Telephone interview and written questionnaire completion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 37058336 BACKGROUND

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 21, 2024
• Study Start: December 2, 2024
• Primary Completion: November 23, 2025
• Study Completion: November 23, 2025
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)