Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647901
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Efficacy of ICG-based NIR Imaging in Intralesional Curettage of Giant Cell Tumors of Bone in Limbs a Prospective Single-center Single-arm Open Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of ICG-based NIR Imaging in Intralesional Curettage of Giant Cell Tumors of Bone in Limbs a Prospective Single-center Single-arm Open Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ICG fluorescence imaging will be applied during the intralesional curettage of giant cell tumor of bone in the limbs This study aims to preliminarily explore whether ICG fluorescent-guided curettage could find small residual tumors and reduce the recurrence rate of tumor
Detailed Description:
Recurrence is a problem in the treatment of giant cell tumor of boneGCTB With the application of high-speed burr and other adjuvant therapy phenol liquid nitrogen freezing cauterization etc the recurrence rate is greatly reduced but it is still as high as 20 The main cause of local recurrence is the difficulty in distinguishing small residual tumor lesions by the naked eye The application of frozen section is limited due to the long-term decalcification of bone specimens
Intraoperative near-infrared NIR imaging is a promising technology expected to solve the above problems It allows for real-time scanning of a wide area with tumor showing fluorescence Such intraoperative fluorescent signals provide objective evidence for the surgeon and are more reliable than subjective visual and tactile information
This study aims to explore whether ICG-based NIR imaging guided curettage could find small residual tumors and reduce the recurrence rate of GCT
Intraoperative near-infrared NIR imaging is a promising technology expected to solve the above problems It allows for real-time scanning of a wide area with tumor showing fluorescence Such intraoperative fluorescent signals provide objective evidence for the surgeon and are more reliable than subjective visual and tactile information
This study aims to explore whether ICG-based NIR imaging guided curettage could find small residual tumors and reduce the recurrence rate of GCT
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