Health TrialsbyHealthPanel

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

ConditionsDermatofibrosarcoma Protuberans (DFSP)Skin Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with DFSPs or sSCC in heads, extremities or trunk

Disqualifiers

seafood/iodine allergy

hyperthyroidism

pregnancy

myasthenia gravis

Trial design

Design model

Parallel

Treatments tested in this trial

  • ICG administration

    Drug

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

  • ICG administration

    Drug

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

  • ICG administration

    Drug

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

  • ICG administration

    Drug

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

Treatment groups

592 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Patients with DFSP in the first experimental groupExperimental treatment 1 intervention
Group B: Patients with DFSP in the second experimental groupExperimental treatment 1 intervention
Group C: Patients with DFSP in the control groupNo intervention 0 interventions
Group D: Patients with sSCC in the first experimental groupExperimental treatment 1 intervention
Group E: Patients with sSCC in the second experimental groupExperimental treatment 1 intervention
Group F: Patients with sSCC in the control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

2-year local recurrence rate

Time frame
up to 24 months

Secondary outcomes

1

number of positive margins

Time frame
through study completion, an average of 2 years
2

sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)

Time frame
through study completion, an average of 2 years
3

Adverse effects

Time frame
through study completion, an average of 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Peking University Third Hospital

Collaborator

Chinese PLA General Hospital

Collaborator

Peking University International Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: