68Ga-B7-H3 Nanobody ImmunoPET in Osteosarcoma

Sponsor
Peking University First Hospital
Study ID
NCT07774533
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Osteosarcoma
  • Osteosarcoma, Recurrent, Refractory

Eligibility Criteria

Sex
ALL
Age
10 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 68Ga-B7-H3 Nanobody PET/CT — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Apr 1, 2026
Status verified
Aug 2026
Primary completion
Aug 5, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 68Ga-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.

Primary Outcome Measure

Lesion detection rate of 68Ga-B7-H3 nanobody PET/CT [ Time Frame: Baseline (at the time of PET/CT imaging) ]

Central Contacts

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