Ignite Creation Date:
2024-05-06 @ 8:58 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02865434
Status:
COMPLETED
Last Update Posted:
2021-08-12
First Post:
2016-08-05
Brief Title:
Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA
Sponsor:
Navidea Biopharmaceuticals
Organization:
Navidea Biopharmaceuticals
Study Overview
Official Title:
An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous IV Injection and Skeletal Joint Imaging With SPECT in Subjects With Active Rheumatoid Arthritis RA and Healthy Controls
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective open-label multicenter dose escalation safety with pharmacokinetics PK and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging
Detailed Description:
A Manocept Platform prospective open-label multicenter dose escalation safety with PK and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging All subjects will receive IV administration at one of 3 mass doses 50 µg 200 µg or 400 µg Within each mass dose group subjects will receive Tc 99m tilmanocept labeled with one of 3 radiolabel doses 1 mCi 5 mCi or 10 mCi
All subjects will have a whole body planar SPECT scan Subjects enrolled in Groups 1-9 will receive a whole body and planar hands scan followed by SPECTCT scans on areas of interest post injection at 60 minutes 15 minutes and 180 minutes 15 minutes Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed at 4 specified time points post injection 15 5 minutes 60 15 minutes 180 15 minutes and 18-20 hours Planar hand scans will be collected at 60 15 minutes and 180 15 minutes post-injection PK blood sampling will be performed before injection within 15 minutes immediately following injection within 5 minutes and at each scanning timepoint Dosimetry tests will be performed at each scanning timepoint PK of urine will be assessed through counts of the bladder wall obtained from cumulative quantitative planar imaging from radiation dosimetry
All subjects will have a whole body planar SPECT scan Subjects enrolled in Groups 1-9 will receive a whole body and planar hands scan followed by SPECTCT scans on areas of interest post injection at 60 minutes 15 minutes and 180 minutes 15 minutes Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed at 4 specified time points post injection 15 5 minutes 60 15 minutes 180 15 minutes and 18-20 hours Planar hand scans will be collected at 60 15 minutes and 180 15 minutes post-injection PK blood sampling will be performed before injection within 15 minutes immediately following injection within 5 minutes and at each scanning timepoint Dosimetry tests will be performed at each scanning timepoint PK of urine will be assessed through counts of the bladder wall obtained from cumulative quantitative planar imaging from radiation dosimetry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None