Viewing Study NCT06610071



Ignite Creation Date: 2024-10-26 @ 3:41 PM
Last Modification Date: 2024-10-26 @ 3:41 PM
Study NCT ID: NCT06610071
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-09-01

Brief Title: NIFR Image-guided Surgery for Malignant Soft Tissue Tumor With Low-dose SWIG Technique
Sponsor: None
Organization: None

Study Overview

Official Title: Near-infrared Fluorescence Image-guided Surgery for Malignant Soft Tissue Tumor With Low-dose Second Window Indocyanine Green Technique a Multicenter Randomized Controlled Trial
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
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: NIFRSWIG
Brief Summary: This research study will evaluate how near-infrared fluorescence NIRF imaging with low-dose second window indocyanine green ICG can assist in the radical resection and pathologic diagnosis of malignant soft tissue sarcoma such as dermatofibrosarcoma protuberans DFSP and skin squamous cell carcinoma sSCC during surgery
Detailed Description: To improve the accuracy of radical resection by reducing the risk of missed diagnosis of positive margin this study will explore clinical application of near-infrared fluorescence imaging with modified low-dose SWIG technique in guiding radical resection of malignant soft tissue tumor The investigators conduct a multi-center multi-subgroup prospective randomized controlled trial The participants will be first stratified according to histological type involving dermatofibrosarcoma protuberans DFSP and skin squamous cell carcinoma sSCC The patients with DFSP or sSCC will be then randomly assigned to three groups Patients in the control group will not receive ICG administration The ICG was injected intravenously 24 hours before surgery at a dose of 025 mgkg in the first experimental group and 25 mgpatient in the second experimental group respectively The patients in the control groups will undergo traditional assessment of surgical marginsThe patients in the experimental groups on the other hand will be scheduled to intraoperative near-infrared fluorescence imaging to scan gross tumor tumor bed and cross-sectional specimen The 2-year local recurrence rate will be regarded as primary outcome The number of positive margins will be compared among groups The investigators will also calculate the sensitivity specificity positive predictive value PPV and negative predictive value NPV with 95 confidence intervals based on fluorescent signal of tumor bed in the experimental groups

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