Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT06778603
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06778603
Study Brief:
Protocol Section:
NCT06778603