Indocyanine green fluorescence to find leftover giant cell tumor tissue during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, single-arm study that gives patients an intravenous dose of indocyanine green (0.25–0.5 mg/kg) 1–6 hours before their planned tumor curettage. After the standard curettage under white light, surgeons will use a near-infrared fluorescence imaging system to scan the bone cavity and identify fluorescence-positive areas. Biopsy samples will be taken from fluorescence-positive sites, fluorescence-negative background, and post-treatment beds and sent for blinded pathological review. The study will compare intraoperative fluorescence findings with pathology to calculate sensitivity, specificity, positive predictive value, negative predictive value, and will also analyze tumor-to-background ratios and microscopic tumor boundary concordance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosed with Giant Cell Tumor of Bone(GCTB), via preoperative biopsy or typical imaging (MRI), and scheduled for surgical resection.
* Capable of understanding the study and voluntarily signing the written informed consent form.

Exclusion Criteria:

* Known severe history of allergy to Indocyanine Green (ICG) or iodine.
* Severe liver dysfunction.
* Women who are pregnant or lactating.

Where it's running

• Shanghai Sixth People's Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Qingcheng Yang, Prof.
• Email: tjyqc@163.com
• Phone: +86 21 6431 9181

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.