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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening. The same treatment therapy will consist of 3 time-points, approximately 1 month apart.
On Day 2, 2.5 mL of Zn-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Zn-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening. The same treatment therapy will consist of 3 time-points, approximately 1 month apart.
UNC Hospitals
Chapel Hill, North Carolina, United States
Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Time frame: Baseline, Month 1
Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Time frame: Baseline, Month 1
Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Time frame: Baseline, Month 2
Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Time frame: Baseline, Month 2
Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Time frame: Baseline, Month 3
Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Time frame: Baseline, Month 3
Change From Baseline to Month 1 in the Pain Score
Patient self-reported pain scores assessed using a Visual Analog Scale (VAS) ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain".
Time frame: Baseline, Month 1 (Day 7)
Change From Baseline to Month 2 in the Pain Score
Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain".
Time frame: Baseline, Month 2 (Day 7)
Change From Baseline to Month 3 in the Pain Score
Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain".
Time frame: Baseline, Month 3 (Day 7)
Change From Baseline to Month 6 in the Pain Score
Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain".
Time frame: Baseline, Month 6
Change From Baseline to Month 12 in the Pain Score
Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain".
Time frame: Baseline, Month 12
Change in American Chronic Pain Association (ACPA) Quality of Life (QOL) Score From Baseline to Month 1
The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life".
Time frame: Baseline, Month 1 (day 7)
Change in ACPA QOL Score From Baseline to Month 2
The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life".
Time frame: Baseline, Month 2 (day 7)
Change in ACPA QOL Score at Month 3
The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life".
Time frame: Baseline, Month 3 (day 7)
Change in ACPA QOL Score at Month 6
The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life".
Time frame: Baseline, Month 6
Change in ACPA QOL Score at Month 12
The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life".
Time frame: Baseline, Month 12
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