Using ICG imaging to improve surgery for giant cell tumors of bone
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
This study is testing if a special imaging technique can help surgeons find and remove all parts of giant cell tumors in the bone to reduce the chances of them coming back after surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | Denosumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06647901 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of indocyanine green (ICG) fluorescence imaging during intralesional curettage for patients with giant cell tumors of bone in the limbs. The goal is to determine if this imaging technique can help identify small residual tumors that may lead to recurrence after surgery. By providing real-time visual feedback, the study aims to enhance the surgeon's ability to remove all tumor tissue effectively. This approach could potentially lower the recurrence rate associated with traditional surgical methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with biopsy-confirmed giant cell tumors of bone located in the limbs who are undergoing their initial treatment.
Not a fit: Patients with known allergies to iodine contrast or indocyanine green, severe hepatic or renal insufficiency, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could significantly reduce the recurrence rate of giant cell tumors of bone, leading to better long-term outcomes for patients.
How similar studies have performed: While the use of ICG imaging is a relatively novel approach in this context, similar imaging techniques have shown promise in other surgical applications, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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: 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.
Where this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Han Wang, MD
- Email: wh23333@126.com
- Phone: +86 13520170664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.