Ignite Creation Date:
2024-05-06 @ 10:03 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03157167
Status:
COMPLETED
Last Update Posted:
2020-07-16
First Post:
2017-05-04
Brief Title:
An Evaluation of Tc 99m Tilmanocept by Intravenous IV and Subcutaneous SC Injection in Kaposi Sarcoma KS
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 a Comparison to Subcutaneous SC Injection in Human Immunodeficiency Virus HIV Subjects Diagnosed With Kaposi Sarcoma KS
Status:
COMPLETED
Status Verified Date:
2020-07
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:
To determine the safety of escalating IV doses of Tc 99m tilmanocept in HIV human immunodeficiency virus subjects with confirmed KS and to compare results obtained from subcutaneous and IV administrations of Tc 99m tilmanocept in the same subjects
Detailed Description:
This is a Manocept Platform prospective single-center open-label non-randomized dose escalation comparative safety study of intravenously and subcutaneously injected Tc 99m tilmanocept in the localization and detection of cutaneous and non-cutaneous KS tumors in subjects with biopsy-confirmed KS Three IV doses µgmCi of tilmanocept will be evaluated in three cohort groups One subcutaneous dose will be evaluated in cohort group 3
This study is designed to evaluate the safety and tolerability of escalating doses of IV Tc 99m tilmanocept and to compare results obtained from IV and subcutaneous administrations of Tc 99m tilmanocept in the same subjects Whole body planar as well as SPECTCT imaging will be performed to provide greater resolution of areas of Tc 99m tilmanocept localization A biopsy of a non-visceral KS lesion will be taken to correlate pathology with Tc 99m tilmanocept localization
This study is designed to evaluate the use of Tc 99m tilmanocept as an imaging agent in HIV-positive subjects with known KS by evaluating localization in known and unknown cutaneous and non-cutaneous lesions
This study is designed to evaluate the safety and tolerability of escalating doses of IV Tc 99m tilmanocept and to compare results obtained from IV and subcutaneous administrations of Tc 99m tilmanocept in the same subjects Whole body planar as well as SPECTCT imaging will be performed to provide greater resolution of areas of Tc 99m tilmanocept localization A biopsy of a non-visceral KS lesion will be taken to correlate pathology with Tc 99m tilmanocept localization
This study is designed to evaluate the use of Tc 99m tilmanocept as an imaging agent in HIV-positive subjects with known KS by evaluating localization in known and unknown cutaneous and non-cutaneous lesions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R44CA192859-01 | NIH | None | httpsreporternihgovquickSearch1R44CA192859-01 |