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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTang Xiaodong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

. Aged 18-65.

Biopsy confirmed giant cell tumor of bone.

The lesions located in the limbs.

This operation is the initial treatment.

Disqualifiers

. 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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: ICG groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

local recurrence rate of tumor

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.

Time frame
From surgery to 2 years after surgery

Secondary outcomes

1

Accuracy of ICG prediction tumor residuals

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.

Time frame
From surgery to 2 weeks after surgery
2

Correlation between fluorescence intensity and pathology findings of tumor residuals

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

Time frame
From surgery to 2 weeks after surgery

Other outcomes

Sponsors and contacts

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

Tang Xiaodong

Lead sponsor

Peking University People's Hospital

Sponsor institution