DTPA Chelation for Symptoms After Gadolinium-assisted MRI
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- 0-10 Scale of Pain Severity (Higher is more severe pain)
研究概览
简要总结
The study aims at gathering additional data on the safety and effectiveness of using intravenous administration of the drugs Ca-DTPA/Zn-DTPA to remove the heavy metal gadolinium from the bodies of patients who have retained it and developed symptoms of Gadolinium Deposition Disease following an MRI in which a gadolinium-containing contrast agent was utilized. The outcome data will include measures of symptom relief after as many as six paired Calcium-DTPA/Zinc-DTPA chelation treatments. The study also aims at gathering additional data before and after DTPA treatment regarding levels of certain cytokines in the patients' blood that have been reported to be abnormally elevated in patients with retained gadolinium.
详细描述
This study aims at gathering additional data on the safety and effectiveness of using intravenous administration of the drug DTPA to remove the heavy metal gadolinium from the bodies of patients who have retained it and developed symptoms of Gadolinium Deposition Disease following an MRI in which a gadolinium-containing contrast agent was utilized. The outcome data will include measures of symptom relief, including chronic pain, skin changes, and cognitive complaints, after as many as six paired Calcium-DTPA/Zinc-DTPA chelation treatments. The study also aims at gathering additional data before and after DTPA treatment regarding levels of certain cytokines (chemical messengers) in the patients' blood that have been reported to be abnormally elevated in patients with retained gadolinium.
DTPA is approved as safe and effective by the federal Food and Drug Administration for the removal of certain radioactive heavy metals, has been in use for more than 60 years, is well tolerated, and has been safely used in three studies, that enrolled 25, 21 and 4 patients respectively who were diagnosed with Gadolinium Deposition Disease.Only the first study reported on symptom improvement, and noted that almost all patients experienced benefit after three paired Calcium-DTPA/Zinc-DTPA chelation treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 - 65 and able to give informed consent.
- •Have had an MRI with contrast at least 3 months and less than 3 years before study enrollment.
- •Have a 24-hour urine analysis 30 days or more post-MRI that documents abnormally high levels of gadolinium excretion.
- •Exhibit within 30 days of the contrast-assisted MRI new onset of 3 or more of the following symptoms:
- •cognitive disturbance,
- •extremity pain,
- •frequent headaches,
- •chest wall pain,
- •skin induration,
- •skin hyper-pigmentation,
- •arthralgia.
- •Have met these Gadolinium Deposition Disease (GDD) diagnostic criteria for at least 3 months.
- •Received the MRI contrast agent Gadobutrol (Gadovist) and no other MRI contrast agents.
排除标准
- •Diagnosed by the patient's treating MD with an autoimmune or rheumatological disorder such as systemic lupus, rheumatoid arthritis or scleroderma;
- •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;
- •taking a medication or medications that could cause 3 or more of the 8 diagnostic symptoms of GDD;
- •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.
- •Having Wilson's Disease, hemochromatosis, cancer (other than non-melanoma skin cancer), impaired kidney function, or heart disease compromising cardiac function or causing arrhythmia;
- •Participating in another protocol involving a pharmacological or other treatment of GDD.
- •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.
- •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.
- •Prior chelation treatment for GDD.
- •Pregnant, nursing, intending to become pregnant in the next 6 months, unwilling to utilized an approved, effective contraception method during the study's duration.
研究组 & 干预措施
Chelation with open-label Ca-DTPA and Zn-DTPA
Six chelation treatments utilizing Ca-DTPA on day 1 and Zn-DTPA on day 2. Paired, 2-chelation day treatments will take place at intervals of one week or more.
干预措施: Calcium DTPA and Zinc DTPA (Drug)
结局指标
主要结局
0-10 Scale of Pain Severity (Higher is more severe pain)
时间窗: 2 days before first DTPA treatment
Rating scale of pain severity
0-10 Scale of Pain Severity
时间窗: One month after sixth 2-day DTPA treatment
Rating scale of pain severity
次要结局
- Gadolinium Deposition Disease Symptom rating scale(one month after sixth DTPA treatment treatment)
- Cognitive Function - Short Form 8a (Promis Item Bank v2.0)(one month after sixth 2-day DTPA chelation)
- Cognitive Function - Short Form 8a (Promis Item Bank v2.0) (Higher score = more cognitive complaint)(2 days before first 2-day DTPA chelation)
- Gadolinium Deposition Disease Symptom rating scale (higher number = symptom is more troubling0(2 days before first DTPA treatment treatment)
研究者
Lorrin M Koran, MD
Professor of Psychiatry and Behavioral Sciences
Stanford University