NIFR Image-guided Surgery for Malignant Soft Tissue Tumor With Low-dose SWIG Technique (NIFR;SWIG)

Near-infrared Fluorescence Image-guided Surgery for Malignant Soft Tissue Tumor With Low-dose Second Window Indocyanine Green Technique: a Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Squamous Cell Carcinoma; Dermatofibrosarcoma Protuberans (DFSP)
• Intervention / Treatment: Drug: ICG administration; Drug: ICG administration; Drug: ICG administration

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 0.25 mg/kg in the first experimental group and 25 mg/patient in the second experimental group, respectively. The patients in the control groups will undergo traditional assessment of surgical margins.The 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 Type: Interventional
• Enrollment (Estimated): 592
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dr. Han; Phone Number: +86-15001222456; Email: hanyudi_301@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with DFSPs or sSCC in heads, extremities or trunk

Exclusion Criteria:

• seafood/iodine allergy
• hyperthyroidism
• pregnancy
• myasthenia gravis
• acute severe hypertension

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with DFSP in the first experimental group; The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.	Drug: ICG administration; The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.; Drug: ICG administration; The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.; Drug: ICG administration; The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group
Experimental: Patients with DFSP in the second experimental group; The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.	Drug: ICG administration; The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.; Drug: ICG administration; The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.; Drug: ICG administration; The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group
No Intervention: Patients with DFSP in the control group
Experimental: Patients with sSCC in the first experimental group; The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.	Drug: ICG administration; The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.; Drug: ICG administration; The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.; Drug: ICG administration; The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group
Experimental: Patients with sSCC in the second experimental group; The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.	Drug: ICG administration; The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.; Drug: ICG administration; The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.; Drug: ICG administration; The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group
No Intervention: Patients with sSCC in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
2-year local recurrence rate	up to 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
number of positive margins	through study completion, an average of 2 years
sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)	through study completion, an average of 2 years
Adverse effects	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
• Collaborators: 1、 Department of Plastic and Reconstructive Surgery, Peking University Third Hospital; 2、 Department of Plastic and Reconstructive Surgery, 1st Medical Center of Chinese PLA General Hospital; 3、 Department of Plastic and Reconstructive Surgery, Peking University International Hospital

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: September 1, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: dermatofibrosarcoma protuberans; near-infrared fluorescence imaging; second window indocyanine green; skin squamous cell carcinoma
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Connective Tissue; Neoplasms, Squamous Cell; Neoplasms, Fibrous Tissue; Fibrosarcoma; Sarcoma; Carcinoma, Squamous Cell; Soft Tissue Neoplasms; Dermatofibrosarcoma
• Other Study ID Numbers: CFH2024-2-4043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will include patient characteristics, tumor location, tumor size and histological type and grade. The number of positive margins will be recorded. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will also be calculated. The adverse effects between first and second experimental groups will be compared. The 2-year local recurrence rate will be viewed as primary outcome.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No