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NCT Number: NCT06778603

B7-H3 NIR Imaging for Osteosarcoma Surgery

Complete removal of all tumor tissue with a wide surgical margin is essential for the treatment of osteosarcoma (OS). However, it's difficult, sometimes impossible, to achieve due to the invisible small satellite lesions and blurry tumor boundaries. Besides, intraoperative frozen-section analysis of resection margins of OS is often restricted by the hard tissues around OS, which makes it impossible to know whether a negative margin is achieved. Herein, based on the high expression of B7-H3 in OS, a targeted probe B7H3-IRDye800CW is synthesized by conjugating anti-B7H3 antibody and IRDye800CW. This trial is aimed to investigate R0-resection rate and 2-y local recurrence rate after using this probe in Musculoskeletal tumor surgery for osteosarcoma as well as the safety parameters of this probe in human.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Musculoskeletal Tumor Center

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Xiaodong Tang/ Musculoskeletal Tumor Center, M.D.

CONTACT

[email protected]

+86-88326150

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Patients with histologically confirmed osteosarcoma of the limbs.
  • 2. the patients has not undergone tumor resection.
  • 3. Age between 18 and 60 years old.
  • 4. No prior systemic treatment for osteosarcoma.
  • 5. Measurable disease as assessed by imaging studies (e.g., MRI, CT).
  • 6. Adequate bone marrow, liver, and renal function.
  • 7. Written informed consent obtained from the patient.

Exclusion criteria

  • 1. History of other malignancies within the past 5 years.
  • 2. Pregnancy or lactation.
  • 3. Known hypersensitivity to any component of the B7H3-based NIR imaging agent.
  • 4. Uncontrolled intercurrent illness that would preclude safe study participation.
  • 5. Prior radiation therapy to the target lesion.
  • 6. Any medical condition that would compromise the patient's ability to undergo surgery or comply with study procedures.
  • 7.Patients not able to sign the Informed Consent.

Treatment and study plan

a targeted probe B7H3-IRDye800CW

Drug

B7H3-IRDye800CW was synthesized by conjugating IRDye800CW NHS Ester and Anti-B7H3 antibody.

Primary outcomes

  1. Safety

    Time frame: 21 days

    According to CTCAE 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaodong Musculoskeletal Tumor Center of PKUPH, M.D.

CONTACT

[email protected]

+86-88326150

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Simcere Pharmaceutical Group Limited

Registry information

Official study title

Resection of Osteosarcoma in Limbs Navigated by B7H3-based NIR Lmaging: a Prospective, Single-center,Single-arm, Exploratory Trial

Acronym: ROLN-B7-H3

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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