OsteosarcomaPhase 1/2ROLN-B7-H3NCT06778603
B7-H3 NIR Imaging for Osteosarcoma Surgery
A Phase 1/2 study testing a targeted probe B7H3-IRDye800CW in people with Osteosarcoma and Resection Margins, run by Peking University People's Hospital at 1 site in China.
Trial summary
Complete removal of all tumor tissue with a wide surgical margin is essential for the treatment of osteosarcoma (OS). However, it's difficult, sometimes impossible, to achieve due to the invisible small satellite lesions and blurry tumor boundaries. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteosarcoma, Resection Margins, B7-H3 Probe
- What is being tested?
- a targeted probe B7H3-IRDye800CW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Patients with histologically confirmed osteosarcoma of the limbs.
- 2. the patients has not undergone tumor resection.
- 3. Age between 18 and 60 years old.
- 4. No prior systemic treatment for osteosarcoma.
- 5. Measurable disease as assessed by imaging studies (e.g., MRI, CT).
- 6. Adequate bone marrow, liver, and renal function.
- 7. Written informed consent obtained from the patient.
Who cannot join
- 1. History of other malignancies within the past 5 years.
- 2. Pregnancy or lactation.
- 3. Known hypersensitivity to any component of the B7H3-based NIR imaging agent.
- 4. Uncontrolled intercurrent illness that would preclude safe study participation.
- 5. Prior radiation therapy to the target lesion.
- 6. Any medical condition that would compromise the patient's ability to undergo surgery or comply with study procedures.
- 7.Patients not able to sign the Informed Consent.
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
Musculoskeletal Tumor Center
Beijing, Beijing Municipality, 100044
Xiaodong Tang/ Musculoskeletal Tumor Center, M.D., +86-88326150, tang15877@126.com
About this study
Official title: Resection of Osteosarcoma in Limbs Navigated by B7H3-based NIR Lmaging: a Prospective, Single-center,Single-arm, Exploratory Trial
Complete removal of all tumor tissue with a wide surgical margin is essential for the treatment of osteosarcoma (OS). However, it's difficult, sometimes impossible, to achieve due to the invisible small satellite lesions and blurry tumor boundaries. Besides, intraoperative frozen-section analysis of resection margins of OS is often restricted by the hard tissues around OS, which makes it impossible to know whether a negative margin is achieved. Herein, based on the high expression of B7-H3 in OS, a targeted probe B7H3-IRDye800CW is synthesized by conjugating anti-B7H3 antibody and IRDye800CW. This trial is aimed to investigate R0-resection rate and 2-y local recurrence rate after using this probe in Musculoskeletal tumor surgery for osteosarcoma as well as the safety parameters of this probe in human.
- Conditions
- Osteosarcoma, Resection Margins, B7-H3 Probe, Local Recurrence
- Being tested
- a targeted probe B7H3-IRDye800CW
- Keywords
- osteosarcoma, resection margins, B7-H3 Targeted Probe, local recurrence rate
- Medical subject headings
- Osteosarcoma, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a targeted probe B7H3-IRDye800CWDrug
B7H3-IRDye800CW was synthesized by conjugating IRDye800CW NHS Ester and Anti-B7H3 antibody.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Drug: a targeted probe B7H3-IRDye800CW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
According to CTCAE 5.0
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Jan 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteosarcomaStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Simcere Pharmaceutical Group Limited
- Responsible party
- Principal investigator, Xie Lu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778603
- Sponsor's protocol ID
- PKUPH-sarcoma 22
- Acronym
- ROLN-B7-H3
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng F, Li C, Wang H, Wang Y, Ren T, He F, Jiang J, Xu J, Wang B, Wu Y, Yu Y, Hu Z, Tian J, Wang S, Tang X. Intraoperative Resection Guidance and Rapid Pathological Diagnosis of Osteosarcoma using B7H3 Targeted Probe under NIR-II Fluorescence Imaging. Adv Sci (Weinh). 2024 Sep;11(33):e2310167. doi: 10.1002/advs.202310167. Epub 2024 Mar 19.
PubMed 38502871
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection of Osteosarcoma in Limbs Navigated by B7H3-based NIR Lmaging: a Prospective, Single-center,Single-arm, Exploratory Trial
- ClinicalTrials.gov ID
- NCT06778603
- Acronym / sponsor ID
- ROLN-B7-H3 / PKUPH-sarcoma 22
- Conditions
- Osteosarcoma, Resection Margins, B7-H3 Probe, Local Recurrence
- Keywords
- osteosarcoma, resection margins, B7-H3 Targeted Probe, local recurrence rate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Simcere Pharmaceutical Group Limited
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jan 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.
Complete removal of all tumor tissue with a wide surgical margin is essential for the treatment of osteosarcoma (OS). However, it's difficult, sometimes impossible, to achieve due to the invisible small satellite lesions and blurry tumor boundaries. Besides, intraoperative frozen-section analysis of resection margins of OS is often restricted by the hard tissues around OS, which makes it impossible to know whether a negative margin is achieved. Herein, based on the high expression of B7-H3 in OS, a targeted probe B7H3-IRDye800CW is synthesized by conjugating anti-B7H3 antibody and IRDye800CW. This trial is aimed to investigate R0-resection rate and 2-y local recurrence rate after using this probe in Musculoskeletal tumor surgery for osteosarcoma as well as the safety parameters of this probe in human.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: a targeted probe B7H3-IRDye800CW |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1. Patients with histologically confirmed osteosarcoma of the limbs.
- 2. the patients has not undergone tumor resection.
- 3. Age between 18 and 60 years old.
- 4. No prior systemic treatment for osteosarcoma.
- 5. Measurable disease as assessed by imaging studies (e.g., MRI, CT).
Key exclusion criteria (7 listed)
- 1. History of other malignancies within the past 5 years.
- 2. Pregnancy or lactation.
- 3. Known hypersensitivity to any component of the B7H3-based NIR imaging agent.
- 4. Uncontrolled intercurrent illness that would preclude safe study participation.
- 5. Prior radiation therapy to the target lesion.
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 |
|---|---|---|
| a targeted probe B7H3-IRDye800CWB7H3-IRDye800CW was synthesized by conjugating IRDye800CW NHS Ester and Anti-B7H3 antibody. | Drug | experimental group |
Primary outcome
Safety
Time frame: 21 days
According to CTCAE 5.0
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 16 Jan 2025.
- Results publication: PubMed 38502871Zeng F, Li C, Wang H, Wang Y, Ren T, He F, Jiang J, Xu J, Wang B, Wu Y, Yu Y, Hu Z, Tian J, Wang S, Tang X. Intraoperative Resection Guidance and Rapid Pathological Diagnosis of Osteosarcoma using B7H3 Targeted Probe under NIR-II Fluorescence Imaging. Adv Sci (Weinh). 2024 Sep;11(33):e2310167. doi: 10.1002/advs.202310167. Epub 2024 Mar 19.
- 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 a targeted probe B7H3-IRDye800CW in people with Osteosarcoma and Resection Margins, run by Peking University 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 7 inclusion and 7 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 16 Jan 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.
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 Xiaodong Musculoskeletal Tumor Center of PKUPH, M.D. (+86-88326150, tang15877@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06778603, which also lists 1 linked publication.
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 16 Jan 2025.