Using ICG imaging to improve surgery for giant cell tumors of bone
Official title: 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
Run by Peking University People's Hospital · NCT06647901 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | Denosumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 23, 2024 |
| Main results expected | August 31, 2026 |
| Study ends | August 31, 2028 |
| Registry record updated | October 18, 2024 |
| Trial ID | NCT06647901 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Peking University People's Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Han Wang, MD
- Email: wh23333@126.com
- Phone: +86 13520170664
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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TRACP-5b test to help diagnose and monitor giant cell tumor of bone
This study tests whether a blood marker, TRACP-5b, can help diagnose and track giant cell tumor of bone in adults.
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Indocyanine green fluorescence to find leftover giant cell tumor tissue during surgery
We will try a dye called indocyanine green with near-infrared imaging during surgery to help surgeons spot any remaining giant cell tumor tissue in people having surgery for GCTB.
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This project tests whether PROMIS questionnaires together with a new smartphone app can track recovery and mobility in adults undergoing surgery for sarcoma or giant cell tumor of bone.
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Using zoledronic acid-loaded bone cement to reduce recurrence of giant cell bone tumors after surgery
This study tests if using a special bone cement with a drug can help prevent giant cell bone tumors from coming back after surgery, compared to regular bone cement.
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Using bisphosphonate to reduce tumor recurrence in bone tumors
This study is testing if using a special bone cement with bisphosphonate during surgery can help prevent giant cell tumors in bones from coming back and improve recovery compared to regular surgery alone.
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Pimicotinib for Japanese people with tenosynovial giant cell tumor (J-MANEUVER)
This trial will test whether pimicotinib is safe, reaches effective blood levels, and improves symptoms in Japanese participants with unresectable tenosynovial giant cell tumor.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.