Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06647901

Efficacy of ICG-based NIR Imaging in Intralesional Curettage of Giant Cell Tumors of Bone in Limbs: a Prospective, Single-center, Single-arm, Open Study

ICG fluorescence imaging will be applied during the intralesional curettage of giant cell tumor of bone in the limbs. This study aims to preliminarily explore whether ICG fluorescent-guided curettage could find small residual tumors and reduce the recurrence rate of tumor.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Han Wang, MD

CONTACT

[email protected]

+86 13520170664

About this study

Recurrence is a problem in the treatment of giant cell tumor of bone(GCTB). With the application of high-speed burr and other adjuvant therapy (phenol, liquid nitrogen freezing, cauterization, etc.), the recurrence rate is greatly reduced, but it is still as high as 20%. The main cause of local recurrence is the difficulty in distinguishing small residual tumor lesions by the naked eye. The application of frozen section is limited due to the long-term decalcification of bone specimens.

Intraoperative near-infrared (NIR) imaging is a promising technology expected to solve the above problems. It allows for real-time scanning of a wide area with tumor showing fluorescence. Such intraoperative fluorescent signals provide objective evidence for the surgeon and are more reliable than subjective visual and tactile information.

This study aims to explore whether ICG-based NIR imaging guided curettage could find small residual tumors and reduce the recurrence rate of GCT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • . Aged 18-65.
  • Biopsy confirmed giant cell tumor of bone.
  • The lesions located in the limbs.
  • This operation is the initial treatment.
  • Denosumab and diphosphonates are not used before surgery.
  • Planned operation is intralesional curettage and filling bone defects with bone cement.
  • Preoperative bone scan and thin layer (layer thickness ≤3.5mm) chest CT plain scan confirmed that the lesion is a single occurrence without metastasis.
  • Subjects fully understand the benefits and risks of this experiment and are still willing to participate and sign the informed consent.

Exclusion criteria

  • . Known allergy to iodine contrast, indocyanine green or bone cement.
  • . Severe hepatic and renal insufficiency.
  • . During pregnancy or lactation.
  • . Have other malignant tumors and are receiving related medical treatment.

Treatment and study plan

ICG (Indocyanine Green)

Drug

Patients will be receive intravenously administrated at a dose of 2 mg/kg on the day before surgery. The drug was dissolved into 250 mL of normal saline and administered using a light-proof infusion apparatus. The time course of administration was 60 min. NIR imaging will be performed during surgery to help identify small tumor residuals.

Primary outcomes

  1. local recurrence rate of tumor

    Time frame: From surgery to 2 years after surgery

    To explore whether based on ICG-based-NIR fluorescence imaging assisted intralesional curettage can reduce the local recurrence rate of giant cell tumor of bone in limbs.

Secondary outcomes

  1. Accuracy of ICG prediction tumor residuals

    Time frame: From surgery to 2 weeks after surgery

    To explore the accuracy of ICG fluorescence in detection of small residual tumor lesions and calculate the sensitivity, specificity, positive predictive value, negative predictive value.

  2. Correlation between fluorescence intensity and pathology findings of tumor residuals

    Time frame: From surgery to 2 weeks after surgery

    To explore the correlation between ICG fluorescence intensity and accuracy of detection of residual tumor lesions.

Study contacts

Contact information is provided by the study sponsor or research team.

Han Wang, MD

CONTACT

[email protected]

+86 13520170664

Xiaodong Tang, MD

CONTACT

[email protected]

+86 8832 6150

Sponsors and collaborators

Lead sponsor

Tang Xiaodong

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Oct 18, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.