A Phase 1/2 interventional study of ICG (Indocyanine Green) in Giant Cell Tumor of Bone, sponsored by Tang Xiaodong. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by Tang Xiaodong · Phase 1/2, Interventional, and Treatment
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.
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.
23 studies on the registry are indexed under Giant Cell Tumor of Bone; 7 are open to participants now.
This study's planned enrollment of 45 is close to the median of 43 across 16 interventional studies indexed under Giant Cell Tumor of Bone.
Browse Giant Cell Tumor of Bone studies →Tang Xiaodong is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ICG (Indocyanine Green)
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.
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
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
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
Plan to share: No
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Studies of the drug tested here: Indocyanine Green
Tang Xiaodong