Osteosarcoma, Osteosarcoma, Recurrent, Refractory
Conditions
Keywords
Osteosarcoma, B7-H3, CD276, ImmunoPET, Gallium-68, Nanobody, PET/CT, Molecular Imaging
Brief summary
This study aims to evaluate the safety, feasibility, and imaging performance of a novel 68Ga-labeled B7-H3 nanobody for immunoPET imaging in patients with osteosarcoma. Participants with suspected or histologically confirmed osteosarcoma will undergo 68Ga-B7-H3 nanobody PET/CT imaging according to the study protocol. Imaging findings will be compared with conventional imaging and, when available, histopathological results. The study will assess tracer biodistribution, tumor uptake, lesion detectability, and safety to determine the potential clinical value of B7-H3-targeted immunoPET for the diagnosis and evaluation of osteosarcoma.
Detailed description
B7-H3 (CD276) is an immune checkpoint molecule that is highly expressed in a variety of malignant tumors, including osteosarcoma, while showing limited expression in most normal tissues. Because of its high tumor-associated expression, B7-H3 has emerged as a promising molecular imaging and therapeutic target. This is a prospective, single-center clinical study designed to evaluate a novel 68Ga-labeled B7-H3 nanobody as an immunoPET imaging agent in patients with osteosarcoma. Eligible participants will receive an intravenous administration of the investigational radiotracer followed by PET/CT imaging at the prespecified imaging time point(s). Safety assessments will include monitoring of adverse events and other clinically relevant evaluations as specified in the protocol. Imaging findings will be analyzed to characterize tracer biodistribution and tumor uptake and will be compared with standard imaging examinations and histopathological findings whenever available. The study is intended to investigate the feasibility and diagnostic performance of 68Ga-B7-H3 nanobody immunoPET for the detection and evaluation of osteosarcoma and to provide clinical evidence supporting the further development of B7-H3-targeted molecular imaging.
Interventions
DIAGNOSTIC_TEST68Ga-B7-H3 Nanobody PET/CT
Participants with osteosarcoma will receive a single intravenous administration of the investigational 68Ga-labeled B7-H3 nanobody followed by PET/CT imaging according to the study protocol. Imaging findings will be analyzed for tracer biodistribution, tumor uptake, lesion detection, and safety.
Sponsors
Peking University First Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All participants will undergo 68Ga-B7-H3 nanobody PET/CT imaging following administration of the investigational radiotracer. This is a single-group, open-label imaging study without randomization or comparator arms.
Eligibility
Sex/Gender
ALL
Age
10 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥10 years. * Histologically confirmed osteosarcoma. * Relapsed or refractory disease following failure of first- or second-line systemic therapy. * Ability to understand the study procedures and provide written informed consent (or assent with parental/legal guardian consent, where applicable).
Exclusion criteria
* Pregnant or breastfeeding. * Severe uncontrolled systemic disease or medical condition that, in the investigator's judgment, may interfere with study participation or image interpretation. * Unable to undergo PET/CT examination. * Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion detection rate of 68Ga-B7-H3 nanobody PET/CT | Baseline (at the time of PET/CT imaging) | Number and proportion of osteosarcoma lesions detected by 68Ga-B7-H3 nanobody PET/CT, using histopathology and/or clinical follow-up as the reference standard. |
| Number of participants with 68Ga-PFBH01-related adverse events | 30 ± 3 days | Number and proportion of participants experiencing one or more adverse events considered related to 68Ga-PFBH01 administration. Adverse events will be recorded from tracer administration through 30 ± 3 days after PET/CT and graded according to the Common Terminology Criteria for Adverse Events (CTCAE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum standardized uptake value (SUVmax) of 68Ga-PFBH01 in osteosarcoma lesions | At the time of PET/CT imaging ("Baseline") | SUVmax of 68Ga-PFBH01 will be measured in osteosarcoma lesions identified on PET/CT. SUVmax represents the maximum voxel-level standardized uptake value within the lesion region of interest. |
Countries
China
Contacts
CONTACTTingfei Gu, M.D
Outcome results
None listed