Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT05359835
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged 18 - 65 and able to give informed consent.
2. Have had an MRI with contrast at least 3 months and less than 3 years before study enrollment.
3. Have a 24-hour urine analysis 30 days or more post-MRI that documents abnormally high levels of gadolinium excretion.
4. Exhibit within 30 days of the contrast-assisted MRI new onset of 3 or more of the following symptoms:
1. cognitive disturbance,
2. extremity pain,
3. frequent headaches,
4. chest wall pain,
5. skin induration,
6. skin hyper-pigmentation,
7. skin pain,
8. arthralgia.
5. Have met these Gadolinium Deposition Disease (GDD) diagnostic criteria for at least 3 months.
6. Received the MRI contrast agent Gadobutrol (Gadovist) and no other MRI contrast agents.
Exclusion Criteria:
1. Diagnosed by the patient's treating MD with an autoimmune or rheumatological disorder such as systemic lupus, rheumatoid arthritis or scleroderma;
2. diagnosed by the patient's treating MD with a condition or conditions that could cause 3 or more of the 8 diagnostic symptoms of GDD;
3. taking a medication or medications that could cause 3 or more of the 8 diagnostic symptoms of GDD;
4. having a condition or conditions and taking a medication or medications that together might account for the presence of 3 or more of the diagnostic symptoms of GDD.
5. Having Wilson's Disease, hemochromatosis, cancer (other than non-melanoma skin cancer), impaired kidney function, or heart disease compromising cardiac function or causing arrhythmia;
6. Participating in another protocol involving a pharmacological or other treatment of GDD.
7. Suffering from a disorder that could raise particular cytokine levels. In addition to autoimmune and rheumatological conditions, these disorders include diabetes mellitus requiring insulin, chronic fatigue syndrome, active infectious disease, covid infection in the past four months, receipt of blood products in the previous 6 months, major depression, and irritable bowel syndrome.
8. Unable for medical reasons or unwilling to discontinue medications known to lower cytokine levels of interest including: lithium, n-acetylcysteine, aspirin, NSAIDs, sertraline and other Selective Serotonin Reuptake Inhibitor antidepressants, and the over-the-counter supplements ashwagandha, astaxanthin, and milk thistle.
9. Prior chelation treatment for GDD.
10. Pregnant, nursing, intending to become pregnant in the next 6 months, unwilling to utilized an approved, effective contraception method during the study's duration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05359835
Study Brief:
Protocol Section:
NCT05359835