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Investigation Into the Safety and Efficacy of ICG-Labeled Fluorescence Imaging Technology in Guiding the Resection of Bone and Soft Tissue Tumors

ConditionsBone NeoplasmsSoft Tissue Neoplasms
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGuangdong Provincial People's Hospital

About this trial

Investigate the application protocol, feasibility, and efficacy of indocyanine green (ICG)-assisted near-infrared (NIR) fluorescence-guided resection in bone and soft tissue tumors. Assess the incidence of adverse events and evaluate the safety of the protocol.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed diagnosis of bone and soft tissue tumors (according to the WHO Classification of Tumours of Soft Tissue and Bone, 4th Edition).

Medically fit to undergo surgical treatment based on preoperative evaluation.

Absence of cardiovascular, anesthesia-related, or other surgical contraindications.

Disqualifiers

Presence of severe or chronic kidney, liver, or pulmonary diseases.

Autonomous thyroid nodules or allergy to iodine/shellfish.

Deemed unable to tolerate surgery based on preoperative evaluation.

Trial population

40

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Indocyanine green (ICG)

    Drug

    Indocyanine green (ICG; National Drug Approval No. H20213567, Ruida Pharmaceuticals) is administered intravenously 24 hours preoperatively at a dose of 2 mg/kg. The drug is dissolved in 250 mL of normal saline using a light-protected infusion set and infused at a constant rate over 60 minutes. Alternatively, a 0.5 mg/kg dose may be administered via IV infusion 1-3 hours before surgery.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: ICG Fluorescence Group1 intervention

Trial outcomes

Primary outcomes

1

Positive Surgical Margin Rate

The proportion of cases with tumor cells detected at the surgical margin during postoperative pathological examination, used to assess the completeness of tumor resection.

Time frame
Within 4 days post-surgery (upon receipt of final pathology report)
2

Positive Residual Lesion Detection Rate

The proportion of intraoperatively detected residual lesions (via fluorescence imaging) confirmed as tumor tissue by pathology, reflecting the accuracy of fluorescence imaging in identifying tumor remnants.

Time frame
Within 4 days post-surgery (upon receipt of final pathology report)
3

Tumor Fluorescence Staining Rate

The success rate of intraoperative tumor visualization using fluorescence imaging after indocyanine green (ICG) injection, evaluating the effectiveness of fluorescence-guided technology.

Time frame
During surgery

Secondary outcomes

1

Local Progression-Free Survival

The time from surgery to local tumor recurrence or progression, primarily assessing the efficacy of surgery in delaying recurrence.

Time frame
From the date of surgery until the date of first documented local progression or death from any cause, whichever occurs first, assessed up to 24 months
2

2-Year Disease-Free Survival (DFS) Rate

The proportion of patients without tumor recurrence or death within 2 years post-surgery, reflecting intermediate-term treatment efficacy and overall prognosis.

Time frame
Form surgery to 2 years after surgery

Other outcomes

Sponsors and contacts

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

Guangdong Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov

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