Giant Cell Tumor of BonePhase 1/2NCT06647901
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
A Phase 1/2 study testing ICG (Indocyanine Green) in people with Giant Cell Tumor of Bone, run by Tang Xiaodong at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Giant Cell Tumor of Bone
- What is being tested?
- ICG (Indocyanine Green)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2024to 31 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Aged 18-65.
- Biopsy confirmed giant cell tumor of bone.
- The lesions located in the limbs.
- This operation is the initial treatment.
- Denosumab and diphosphonates are not used before surgery.
- Planned operation is intralesional curettage and filling bone defects with bone cement.
- Preoperative bone scan and thin layer (layer thickness ≤3.5mm) chest CT plain scan confirmed that the lesion is a single occurrence without metastasis.
- Subjects fully understand the benefits and risks of this experiment and are still willing to participate and sign the informed consent.
Who cannot join
- . 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Han Wang, MD, +86 13520170664, wh23333@126.com
About this study
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.
Read the detailed description
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.
- Conditions
- Giant Cell Tumor of Bone
- Being tested
- ICG (Indocyanine Green)
- Keywords
- ICG, Giant cell tumor of bone, curettage
- Medical subject headings
- Giant Cell Tumor of Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| ICG group | Experimental | Not described Receives: Drug: ICG (Indocyanine Green) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From surgery to 2 years after surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: From surgery to 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start23 Aug 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell Tumor of BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang Xiaodong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tang Xiaodong, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647901
- Sponsor's protocol ID
- PKUPH-ICGGCT-1
- Status last verified
- May 2024
- First submitted
- 16 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06647901
- Acronym / sponsor ID
- PKUPH-ICGGCT-1
- Conditions
- Giant Cell Tumor of Bone
- Keywords
- ICG, Giant cell tumor of bone, curettage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tang XiaodongUniversity, hospital or other
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG group | Experimental | Drug: ICG (Indocyanine Green) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- . Aged 18-65.
- Biopsy confirmed giant cell tumor of bone.
- The lesions located in the limbs.
- This operation is the initial treatment.
- Denosumab and diphosphonates are not used before surgery.
Key exclusion criteria (4 listed)
- . 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | ICG group |
Primary outcome
local recurrence rate of tumor
Time frame: From surgery to 2 years after surgery
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.
2 secondary outcomes
Accuracy of ICG prediction tumor residuals
Time frame: From surgery to 2 weeks after surgery
Correlation between fluorescence intensity and pathology findings of tumor residuals
Time frame: From surgery to 2 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ICG (Indocyanine Green) in people with Giant Cell Tumor of Bone, run by Tang Xiaodong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Han Wang, MD (+86 13520170664, wh23333@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local recurrence rate of tumor (time frame: From surgery to 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.