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
1 other identifier
interventional
592
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2024
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2024
CompletedFirst Posted
Study publicly available on registry
September 24, 2024
CompletedStudy Start
First participant enrolled
October 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2030
September 24, 2024
September 1, 2024
4.1 years
September 1, 2024
September 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
2-year local recurrence rate
up to 24 months
Secondary Outcomes (3)
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
Study Arms (6)
Patients with DFSP in the first experimental group
EXPERIMENTALThe ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.
Patients with DFSP in the second experimental group
EXPERIMENTALThe ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.
Patients with DFSP in the control group
NO INTERVENTIONPatients with sSCC in the first experimental group
EXPERIMENTALThe ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.
Patients with sSCC in the second experimental group
EXPERIMENTALThe ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.
Patients with sSCC in the control group
NO INTERVENTIONInterventions
The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.
Eligibility Criteria
You may qualify if:
- Patients with DFSPs or sSCC in heads, extremities or trunk
You may not qualify if:
- seafood/iodine allergy
- hyperthyroidism
- pregnancy
- myasthenia gravis
- acute severe hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical Collegelead
- 1、 Department of Plastic and Reconstructive Surgery, Peking University Third Hospitalcollaborator
- 2、 Department of Plastic and Reconstructive Surgery, 1st Medical Center of Chinese PLA General Hospitalcollaborator
- 3、 Department of Plastic and Reconstructive Surgery, Peking University International Hospitalcollaborator
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 1, 2024
First Posted
September 24, 2024
Study Start
October 30, 2024
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 30, 2030
Last Updated
September 24, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
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.