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

NCT06979115 | Not Yet Recruiting DMC

• 1 other identifier: ICG-BST
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone Neoplasms; Soft Tissue Neoplasms

Keywords

Soft tissue neoplasms; Bone neoplasms; Indocyanine green; Near-infrared

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

  During surgery

Secondary Outcomes (2)

• Local Progression-Free Survival

  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-Year Disease-Free Survival (DFS) Rate

  Form surgery to 2 years after surgery

Study Arms (1)

ICG Fluorescence Group

For patients with bone and soft tissue tumors, indocyanine green (ICG) is administered intravenously preoperatively. A tailored surgical plan is developed based on tumor location, anatomical complexity, histological subtype, and tumor stage. During surgery, a near-infrared (NIR) fluorescence imaging system is utilized for real-time intraoperative imaging and fluorescence-guided verification of tumor margins. Postoperatively, pathological examination of resected specimens is performed, and the positive margin rate is calculated based on histopathological findings.

Drug: Indocyanine green (ICG)

Interventions

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.

ICG Fluorescence Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 516008, China

Location

MeSH Terms

Conditions

Bone Neoplasms; Soft Tissue Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Zhang Yu, Ph.D.

CONTACT

8613602744495; luck_2001@126.com

Yan Yuan, Ph.D.

CONTACT

8613178504143; Yuan_Yan2021@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 18, 2025
• Study Start: May 25, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)