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Trial Title:
NIFR Image-guided Surgery for Malignant Soft Tissue Tumor With Low-dose SWIG Technique
NCT ID:
NCT06610071
Condition:
Dermatofibrosarcoma Protuberans (DFSP)
Skin Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma, Squamous Cell
Soft Tissue Neoplasms
Dermatofibrosarcoma
Sarcoma
Conditions: Keywords:
near-infrared fluorescence imaging
second window indocyanine green
dermatofibrosarcoma protuberans
skin squamous cell carcinoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
ICG administration
Description:
The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the
first experimental group.
Arm group label:
Patients with DFSP in the first experimental group
Intervention type:
Drug
Intervention name:
ICG administration
Description:
The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in
the second experimental group.
Arm group label:
Patients with DFSP in the second experimental group
Intervention type:
Drug
Intervention name:
ICG administration
Description:
The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the
first experimental group
Arm group label:
Patients with sSCC in the first experimental group
Intervention type:
Drug
Intervention name:
ICG administration
Description:
The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in
the second experimental group.
Arm group label:
Patients with sSCC in the second experimental group
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
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with DFSPs or sSCC in heads, extremities or trunk
Exclusion Criteria:
- seafood/iodine allergy
- hyperthyroidism
- pregnancy
- myasthenia gravis
- acute severe hypertension
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 30, 2024
Completion date:
December 30, 2030
Lead sponsor:
Agency:
The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Agency class:
Other
Collaborator:
Agency:
1、 Department of Plastic and Reconstructive Surgery, Peking University Third Hospital
Agency class:
Other
Collaborator:
Agency:
2、 Department of Plastic and Reconstructive Surgery, 1st Medical Center of Chinese PLA General Hospital
Agency class:
Other
Collaborator:
Agency:
3、 Department of Plastic and Reconstructive Surgery, Peking University International Hospital
Agency class:
Other
Source:
The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06610071
https://www.frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.984857/full
