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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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090418
Enrollment
Unknown
Registered
2024-09-29
Start date
2024-08-23
Completion date
Unknown
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant cell tumor of bone

Interventions

Experimental group:ICG-based-NIR fluorescence imaging assisted intralesional curettage

Sponsors

Musculoskeletal tumor center, Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1). Aged 18-65. 2) Biopsy confirmed giant cell tumor of bone. 3) The lesions located in the limbs. 4) This operation is the initial treatment. 5) Denosumab and diphosphonates are not used before surgery. 6) Planned operation is intralesional curettage and filling bone defects with bone cement. 7) Preoperative bone scan and thin layer (layer thickness =3.5mm) chest CT plain scan confirmed that the lesion is a single occurrence without metastasis. 8) Subjects fully understand the benefits and risks of this experiment and are still willing to participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1). Known allergy to iodine contrast, indocyanine green or bone cement. 2). Severe hepatic and renal insufficiency. 3). During pregnancy or lactation. 4). Have other malignant tumors and are receiving related medical treatment.

Design outcomes

Primary

MeasureTime frame
Local recurrence rate;

Secondary

MeasureTime frame
Accuracy of ICG fluorescence predicting residual tumor lesions;Correlation between ICG fluorescence intensity and pathological results of residual tumor lesions;

Countries

China

Contacts

Public ContactTang Xiaodong

Peking University People's Hospital

Tang15877@126.com+86 10 8832 6152

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026