Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease
| Status: | Terminated |
|---|---|
| Conditions: | Migraine Headaches, Orthopedic, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/17/2018 |
| Start Date: | October 2016 |
| End Date: | January 31, 2017 |
Investigator Initiated Investigational New Drug Application to Study the Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease
Purpose: There are two goals we have for this prospective single arm study; to see an
increase in the amount of gadolinium in 24 hour urine collection following each infusion
treatment with Calcium and Zinc DTPA, and to see a reduction or elimination of gadolinium
deposition disease (GDD) symptoms.
Participants: Twenty (20) patients who are suffering from gadolinium deposition disease (GDD)
Procedures: Over a series of three (3) treatment time-points patients will be treated with IV
Ca-DTPA on day one, and Zn-DTPA on day two.
increase in the amount of gadolinium in 24 hour urine collection following each infusion
treatment with Calcium and Zinc DTPA, and to see a reduction or elimination of gadolinium
deposition disease (GDD) symptoms.
Participants: Twenty (20) patients who are suffering from gadolinium deposition disease (GDD)
Procedures: Over a series of three (3) treatment time-points patients will be treated with IV
Ca-DTPA on day one, and Zn-DTPA on day two.
Inclusion Criteria: Exhibiting 3 or greater of the following symptoms which must be present
after having been administered a GBCA:
- Cognitive disturbance
- Extremity pain
- Headache
- Chest wall pain
- Skin induration
- Skin hyperpigmentation
- Skin pain
- Arthralgia
Exclusion Criteria:
- Pregnant or lactating
- Less than 18 years old
- No evidence of gadolinium (has to have shown previous demonstration of Gd by urine
analysis or bone biopsy)
- Known connective tissue disease such as Systemic Lupus Erythematosus or Scleroderma
- Severe hemochromatosis or Wilson's disease
- Glomerular Filtration Rate (GFR) ≤ 60
- Have had an investigational drug within last 30 days
- Unable to give written consent
- Multiple Sclerosis
- Chronic heart failure
- Cirrhosis of the liver
We found this trial at
1
site
Click here to add this to my saved trials
