68Ga-B7-H3 Nanobody ImmunoPET in Osteosarcoma

NCT07774533 | Recruiting Early Phase 1

• 1 other identifier: PFBH01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteosarcoma; Osteosarcoma, Recurrent, Refractory

Keywords

Osteosarcoma; B7-H3; CD276; ImmunoPET; Gallium-68; Nanobody; PET/CT; Molecular Imaging

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (at the time of PET/CT imaging)

• 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).

  30 ± 3 days

Secondary Outcomes (1)

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

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

Study Arms (1)

68Ga-B7-H3 Nanobody PET/CT

EXPERIMENTAL

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.

Diagnostic Test: 68Ga-B7-H3 Nanobody PET/CT

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.

68Ga-B7-H3 Nanobody PET/CT

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (1)

• Qiu 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 RESULT

MeSH Terms

Conditions

Osteosarcoma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tingfei Gu, M.D

CONTACT

010-83572913; tingfei.gu@stx.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 19, 2026
• Study Start: April 1, 2026
• Primary Completion: August 5, 2026
• Study Completion: September 30, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication and available for 5 years.
• Access Criteria: De-identified individual participant data and supporting information may be made available to qualified researchers upon reasonable request for scientifically valid research purposes. Requests should be directed to the corresponding author and should include a research proposal describing the objectives and planned analyses. Access will be subject to review and approval by the study investigators and applicable institutional and ethical requirements. A data use agreement may be required before data are released. Data that could compromise participant privacy will not be shared.

Locations

CN (1)