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68Ga-B7-H3 Nanobody ImmunoPET in Osteosarcoma

ConditionsOsteosarcomaOsteosarcoma, Recurrent, Refractory
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age10-80
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: 68Ga-B7-H3 Nanobody PET/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Lesion detection rate of 68Ga-B7-H3 nanobody PET/CT

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.

Time frame
Baseline (at the time of PET/CT imaging)
2

Number of participants with 68Ga-PFBH01-related adverse events

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).

Time frame
30 ± 3 days

Secondary outcomes

1

Maximum standardized uptake value (SUVmax) of 68Ga-PFBH01 in osteosarcoma lesions

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.

Time frame
At the time of PET/CT imaging ("Baseline")

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University First Hospital

Lead sponsor

Source ClinicalTrials.gov
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