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

NCT06610071 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 592

Last updated 2024-09-24

No results posted yet for this study

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.

Conditions

  • Dermatofibrosarcoma Protuberans (DFSP)
  • Skin Squamous Cell Carcinoma

Interventions

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

DRUG

ICG administration

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

Sponsors & Collaborators

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

    collaborator UNKNOWN

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

    collaborator UNKNOWN

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

    collaborator UNKNOWN

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-30
Primary Completion
2028-12-31
Completion
2030-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06610071 on ClinicalTrials.gov