Bone NeoplasmsICG-BSTNCT06979115
Investigation Into the Safety and Efficacy of ICG-Labeled Fluorescence Imaging Technology in Guiding the Resection of Bone and Soft Tissue Tumors
An observational study of Bone Neoplasms and Soft Tissue Neoplasms, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Investigate the application protocol, feasibility, and efficacy of indocyanine green (ICG)-assisted near-infrared (NIR) fluorescence-guided resection in bone and soft tissue tumors. Assess the incidence of adverse events and evaluate the safety of the protocol. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Neoplasms, Soft Tissue Neoplasms
- What is being tested?
- Indocyanine green (ICG)
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2025to 31 Dec 2028
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 40
Who may be able to join
- Histologically confirmed diagnosis of bone and soft tissue tumors (according to the WHO Classification of Tumours of Soft Tissue and Bone, 4th Edition).
- Medically fit to undergo surgical treatment based on preoperative evaluation.
- Absence of cardiovascular, anesthesia-related, or other surgical contraindications.
Who cannot join
- Presence of severe or chronic kidney, liver, or pulmonary diseases.
- Autonomous thyroid nodules or allergy to iodine/shellfish.
- Deemed unable to tolerate surgery based on preoperative evaluation.
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
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 516008
Zhang Yu, Ph.D., +8613178504143, luck_2001@126.com
Yan Yuan, Ph.D., Yuan_Yan2021@163.com
About this study
Investigate the application protocol, feasibility, and efficacy of indocyanine green (ICG)-assisted near-infrared (NIR) fluorescence-guided resection in bone and soft tissue tumors. Assess the incidence of adverse events and evaluate the safety of the protocol.
Read the detailed description
This research focuses on improving surgical outcomes for patients with bone and soft tissue tumors, a challenging area of cancer treatment. Surgeons face a critical dilemma: removing too much tissue can permanently harm a patient's mobility or function, while removing too little risks leaving behind cancer cells, which may lead to recurrence. Current methods rely heavily on the surgeon's experience and real-time visual or tactile feedback during surgery, but these approaches can be subjective and may miss hidden tumor cells. Traditional tools like frozen tissue analysis during surgery are time-consuming, disrupt the operation, and may not provide accurate results, especially for bone tumors, which require complex processing.
To address these challenges, this study explores an innovative imaging technology called near-infrared (NIR) fluorescence guided surgery, which uses a safe, FDA-approved dye called indocyanine green (ICG). ICG is injected into the patient before surgery and glows under special infrared light, helping surgeons "see" cancer cells in real time. This technology has already proven effective in other cancers (e.g., liver, breast, and colorectal tumors) by highlighting hard-to-detect lesions, guiding lymph node removal, and ensuring complete tumor excision. However, its use in bone and soft tissue tumors-a field with unique anatomical and biological complexities-remains understudied.
Key Goals of the Study:
Tumor Visualization: Test how effectively ICG can "light up" bone and soft tissue tumors under NIR imaging, and determine the optimal timing and methods for administering the dye.
Precision Surgery: Evaluate whether NIR-guided surgery helps surgeons achieve cleaner tumor margins (i.e., removing all cancer cells while sparing healthy tissue).
Accuracy Validation: Compare the fluorescent imaging results with post-surgery pathology reports to confirm if the technology reliably predicts tumor presence.
Practical Insights: Identify factors that might affect the stability and reliability of the imaging system in real-world surgical settings.
Why This Matters:
For Patients: This technology could reduce the risk of cancer recurrence, minimize unnecessary tissue removal, and improve recovery outcomes.
For Surgeons: It offers an objective, real-time tool to enhance decision-making during complex tumor surgeries.
For Cancer Care: If successful, it could establish new standards for precision in orthopedic oncology and inspire broader applications in other understudied cancers.
Real-World Examples:
In liver cancer surgery, ICG has helped surgeons detect tiny, hidden metastases that standard imaging missed.
For lung metastases from sarcoma, ICG-guided removal of suspicious tissue led to a high rate of confirmed cancer cells in additional samples.
Safety and Accessibility:
ICG is widely used in other medical fields, with a strong safety profile approved by global regulatory agencies. The study builds on existing evidence while addressing gaps specific to bone and soft tissue tumors.
By bridging the gap between advanced imaging technology and the unique needs of orthopedic oncology, this research aims to empower surgeons with better tools and give patients a stronger chance at lasting recovery
- Conditions
- Bone Neoplasms, Soft Tissue Neoplasms
- Being tested
- Indocyanine green (ICG)
- Keywords
- Soft tissue neoplasms, Bone neoplasms, Indocyanine green, Near-infrared
- Medical subject headings
- Bone Neoplasms, Soft Tissue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green (ICG)Drug
Indocyanine green (ICG; National Drug Approval No. H20213567, Ruida Pharmaceuticals) is administered intravenously 24 hours preoperatively at a dose of 2 mg/kg. The drug is dissolved in 250 mL of normal saline using a light-protected infusion set and infused at a constant rate over 60 minutes. Alternatively, a 0.5 mg/kg dose may be administered via IV infusion 1-3 hours before surgery.
| Study group | Role | What they receive |
|---|---|---|
| ICG Fluorescence Group | For patients with bone and soft tissue tumors, indocyanine green (ICG) is administered intravenously preoperatively. A tailored surgical plan is developed based on tumor location, anatomical complexity, histological subtype, and tumor stage. During surgery, a near-infrared (NIR) fluorescence imaging system is utilized for real-time intraoperative imaging and fluorescence-guided verification of tumor margins. Postoperatively, pathological examination of resected specimens is performed, and the positive margin rate is calculated based on histopathological findings. Receives: Drug: Indocyanine green (ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Surgical Margin Rate
The proportion of cases with tumor cells detected at the surgical margin during postoperative pathological examination, used to assess the completeness of tumor resection.
Measured: Within 4 days post-surgery (upon receipt of final pathology report)
Positive Residual Lesion Detection Rate
The proportion of intraoperatively detected residual lesions (via fluorescence imaging) confirmed as tumor tissue by pathology, reflecting the accuracy of fluorescence imaging in identifying tumor remnants.
Measured: Within 4 days post-surgery (upon receipt of final pathology report)
Tumor Fluorescence Staining Rate
The success rate of intraoperative tumor visualization using fluorescence imaging after indocyanine green (ICG) injection, evaluating the effectiveness of fluorescence-guided technology.
Measured: During surgery
Secondary outcomes (2)
Local Progression-Free Survival
The time from surgery to local tumor recurrence or progression, primarily assessing the efficacy of surgery in delaying recurrence.
Measured: From the date of surgery until the date of first documented local progression or death from any cause, whichever occurs first, assessed up to 24 months
2-Year Disease-Free Survival (DFS) Rate
The proportion of patients without tumor recurrence or death within 2 years post-surgery, reflecting intermediate-term treatment efficacy and overall prognosis.
Measured: Form surgery to 2 years 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 May 2025
- Study start25 May 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone NeoplasmsStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979115
- Sponsor's protocol ID
- ICG-BST
- Acronym
- ICG-BST
- Status last verified
- Mar 2025
- First submitted
- 30 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data might still be actively analyzed for follow-up studies, and premature sharing could compromise ongoing work or publications.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Safety and Efficacy of ICG-Labeled Fluorescence Imaging Technology in Guiding the Resection of Bone and Soft Tissue Tumors
- ClinicalTrials.gov ID
- NCT06979115
- Acronym / sponsor ID
- ICG-BST / ICG-BST
- Conditions
- Bone Neoplasms, Soft Tissue Neoplasms
- Keywords
- Soft tissue neoplasms, Bone neoplasms, Indocyanine green, Near-infrared
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 May 2025 (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.
Investigate the application protocol, feasibility, and efficacy of indocyanine green (ICG)-assisted near-infrared (NIR) fluorescence-guided resection in bone and soft tissue tumors. Assess the incidence of adverse events and evaluate the safety of the protocol.
Detailed description
This research focuses on improving surgical outcomes for patients with bone and soft tissue tumors, a challenging area of cancer treatment. Surgeons face a critical dilemma: removing too much tissue can permanently harm a patient's mobility or function, while removing too little risks leaving behind cancer cells, which may lead to recurrence. Current methods rely heavily on the surgeon's experience and real-time visual or tactile feedback during surgery, but these approaches can be subjective and may miss hidden tumor cells. Traditional tools like frozen tissue analysis during surgery are time-consuming, disrupt the operation, and may not provide accurate results, especially for bone tumors, which require complex processing.
To address these challenges, this study explores an innovative imaging technology called near-infrared (NIR) fluorescence guided surgery, which uses a safe, FDA-approved dye called indocyanine green (ICG). ICG is injected into the patient before surgery and glows under special infrared light, helping surgeons "see" cancer cells in real time. This technology has already proven effective in other cancers (e.g., liver, breast, and colorectal tumors) by highlighting hard-to-detect lesions, guiding lymph node removal, and ensuring complete tumor excision. However, its use in bone and soft tissue tumors-a field with unique anatomical and biological complexities-remains understudied.
Key Goals of the Study:
Tumor Visualization: Test how effectively ICG can "light up" bone and soft tissue tumors under NIR imaging, and determine the optimal timing and methods for administering the dye.
Precision Surgery: Evaluate whether NIR-guided surgery helps surgeons achieve cleaner tumor margins (i.e., removing all cancer cells while sparing healthy tissue).
Accuracy Validation: Compare the fluorescent imaging results with post-surgery pathology reports to confirm if the technology reliably predicts tumor presence.
Practical Insights: Identify factors that might affect the stability and reliability of the imaging system in real-world surgical settings.
Why This Matters:
For Patients: This technology could reduce the risk of cancer recurrence, minimize unnecessary tissue removal, and improve recovery outcomes.
For Surgeons: It offers an objective, real-time tool to enhance decision-making during complex tumor surgeries.
For Cancer Care: If successful, it could establish new standards for precision in orthopedic oncology and inspire broader applications in other understudied cancers.
Real-World Examples:
In liver cancer surgery, ICG has helped surgeons detect tiny, hidden metastases that standard imaging missed.
For lung metastases from sarcoma, ICG-guided removal of suspicious tissue led to a high rate of confirmed cancer cells in additional samples.
Safety and Accessibility:
ICG is widely used in other medical fields, with a strong safety profile approved by global regulatory agencies. The study builds on existing evidence while addressing gaps specific to bone and soft tissue tumors.
By bridging the gap between advanced imaging technology and the unique needs of orthopedic oncology, this research aims to empower surgeons with better tools and give patients a stronger chance at lasting recovery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG Fluorescence Group | – | Drug: Indocyanine green (ICG)For patients with bone and soft tissue tumors, indocyanine green (ICG) is administered intravenously preoperatively. A tailored surgical plan is developed based on tumor location, anatomical complexity, histological subtype, and tumor stage. During surgery, a near-infrared (NIR) fluorescence imaging system is utilized for real-time intraoperative imaging and fluorescence-guided verification of tumor margins. Postoperatively, pathological examination of resected specimens is performed, and the positive margin rate is calculated based on histopathological findings. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 40
Key inclusion criteria (3 listed)
- Histologically confirmed diagnosis of bone and soft tissue tumors (according to the WHO Classification of Tumours of Soft Tissue and Bone, 4th Edition).
- Medically fit to undergo surgical treatment based on preoperative evaluation.
- Absence of cardiovascular, anesthesia-related, or other surgical contraindications.
Key exclusion criteria (3 listed)
- Presence of severe or chronic kidney, liver, or pulmonary diseases.
- Autonomous thyroid nodules or allergy to iodine/shellfish.
- Deemed unable to tolerate surgery based on preoperative evaluation.
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 |
|---|---|---|
| Indocyanine green (ICG)Indocyanine green (ICG; National Drug Approval No. H20213567, Ruida Pharmaceuticals) is administered intravenously 24 hours preoperatively at a dose of 2 mg/kg. The drug is dissolved in 250 mL of normal saline using a light-protected infusion set and infused at a constant rate over 60 minutes. Alternatively, a 0.5 mg/kg dose may be administered via IV infusion 1-3 hours before surgery. | Drug | ICG Fluorescence Group |
Primary outcome
Positive Surgical Margin Rate
Time frame: Within 4 days post-surgery (upon receipt of final pathology report)
The proportion of cases with tumor cells detected at the surgical margin during postoperative pathological examination, used to assess the completeness of tumor resection.
Positive Residual Lesion Detection Rate
Time frame: Within 4 days post-surgery (upon receipt of final pathology report)
The proportion of intraoperatively detected residual lesions (via fluorescence imaging) confirmed as tumor tissue by pathology, reflecting the accuracy of fluorescence imaging in identifying tumor remnants.
Tumor Fluorescence Staining Rate
Time frame: During surgery
The success rate of intraoperative tumor visualization using fluorescence imaging after indocyanine green (ICG) injection, evaluating the effectiveness of fluorescence-guided technology.
2 secondary outcomes
Local Progression-Free Survival
Time frame: From the date of surgery until the date of first documented local progression or death from any cause, whichever occurs first, assessed up to 24 months
2-Year Disease-Free Survival (DFS) Rate
Time frame: Form surgery to 2 years 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 May 2025.
- Individual participant dataSharing planned: No. Data might still be actively analyzed for follow-up studies, and premature sharing could compromise ongoing work or publications.
Related trials for Bone Neoplasms
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
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?
An observational study of Bone Neoplasms and Soft Tissue Neoplasms, run by Guangdong Provincial People's Hospital 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 18 May 2025. 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.
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 Zhang Yu, Ph.D. (8613602744495, luck_2001@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Surgical Margin Rate (time frame: Within 4 days post-surgery (upon receipt of final pathology report)). The study lists 3 primary outcomes in all. 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 May 2025.