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

NCT ID: NCT06610071

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

592 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2030-12-30

Brief Summary

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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

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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.

Conditions

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Dermatofibrosarcoma Protuberans (DFSP) Skin Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

ICG administration

Intervention Type DRUG

The 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

The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.

Group Type EXPERIMENTAL

ICG administration

Intervention Type DRUG

The 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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

ICG administration

Intervention Type DRUG

The 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

The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.

Group Type EXPERIMENTAL

ICG administration

Intervention Type DRUG

The 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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ICG administration

The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.

Intervention Type DRUG

ICG administration

The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.

Intervention Type 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

Intervention Type DRUG

ICG administration

The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* seafood/iodine allergy
* hyperthyroidism
* pregnancy
* myasthenia gravis
* acute severe hypertension
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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1、 Department of Plastic and Reconstructive Surgery, Peking University Third Hospital

UNKNOWN

Sponsor Role collaborator

2、 Department of Plastic and Reconstructive Surgery, 1st Medical Center of Chinese PLA General Hospital

UNKNOWN

Sponsor Role collaborator

3、 Department of Plastic and Reconstructive Surgery, Peking University International Hospital

UNKNOWN

Sponsor Role collaborator

The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

OTHER

Sponsor Role lead

Responsible Party

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Lei Cui

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Dr. Han

Role: CONTACT

+86-15001222456

Related Links

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Other Identifiers

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CFH2024-2-4043

Identifier Type: -

Identifier Source: org_study_id

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