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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Intravenous administration of 2.5 mL (500 mg) of Ca-DTPA over one minute, followed by 900 mL of normal saline infusion over about 90 minutes, followed by 2.5 mL (500 mg) of Ca-DTPA over one minute, followed by infusion of the remaining 100 mL of normal saline over about 10 minutes. Procedure repeated with Zn-DTPA the following day. Two-day procedure repeated at an interval of one week or more for a total of six 2-day treatment sessions.
Stanford University Medical Center
Stanford, California, United States
0-10 Scale of Pain Severity (Higher is more severe pain)
Rating scale of pain severity
Time frame: 2 days before first DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Time frame: 5-6 days after first 2-day DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Time frame: 5-6 days after second 2-day DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Time frame: 5-6 days after third 2-day DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Time frame: 5-6 days after fourth 2-day DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Time frame: 5-6 days after fifth 2-day DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Time frame: 5-6 days after sixth 2-day DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Time frame: One month after sixth 2-day DTPA treatment
Gadolinium Deposition Disease Symptom rating scale (higher number = symptom is more troubling0
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Scale rating common symptoms seen in Gadolinium Deposition Disease
Time frame: 2 days before first DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Scale rating common symptoms seen in Gadolinium Deposition Disease
Time frame: 5 to 6 days after first DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Scale rating common symptoms seen in Gadolinium Deposition Disease
Time frame: 5 to 6 days after third DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Scale rating common symptoms seen in Gadolinium Deposition Disease
Time frame: 5 to 6 days after fourth DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Scale rating common symptoms seen in Gadolinium Deposition Disease
Time frame: 5 to 6 days after fifth DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Scale rating common symptoms seen in Gadolinium Deposition Disease
Time frame: 5 to 6 days after sixth DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Scale rating common symptoms seen in Gadolinium Deposition Disease
Time frame: one month after sixth DTPA treatment treatment
Cognitive Function - Short Form 8a (Promis Item Bank v2.0) (Higher score = more cognitive complaint)
Measure of cognitive function
Time frame: 2 days before first 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Time frame: 5 to 6 after first 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Time frame: 5 to 6 after second 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Time frame: 5 to 6 after third 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Time frame: 5 to 6 after fourth 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Time frame: 5 to 6 after fifth 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Time frame: 5 to 6 after sixth 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Time frame: one month after sixth 2-day DTPA chelation