Clinical trial · Interventional
68Ga-B7-H3 Nanobody ImmunoPET in Osteosarcoma
Clinical Evaluation of a 68Ga-Labeled B7-H3 Nanobody for ImmunoPET Imaging in Patients With Osteosarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Osteosarcoma, Recurrent, Refractory | Osteosarcoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-B7-H3 Nanobody PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-B7-H3 Nanobody PET/CT
- description
- 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.
- interventionNames
- Diagnostic Test: 68Ga-B7-H3 Nanobody PET/CT
Primary outcomes (2)
- measure
- Lesion detection rate of 68Ga-B7-H3 nanobody PET/CT
- timeFrame
- Baseline (at the time of PET/CT imaging)
- description
- 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.
- measure
- Number of participants with 68Ga-PFBH01-related adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTQiu Y, Gu T, Wang T, Mulati Y, Sun X, Yang Q, Song L, Yuan T, Fan Y, Kang L, Cai W. Integrated radio-theranostics using a [89Zr]Zr-/[177Lu]Lu-labeled B7-H3 antibody-drug conjugate for prostate cancer. Theranostics. 2026 Apr 16;16(11):6132-6144. doi: 10.7150/thno.125878. eCollection 2026. PMID 42094601