Imaging solid tumors using a targeted radioactive probe
Official title: Study of B7-H3 Mediated Tumor Immune Response Using a Whole-Body Kinetic Approach in Whole-Body PET
Run by Peking University Cancer Hospital & Institute · NCT06454955 · Data updated 2026-11-12
This study is testing a new radioactive probe to see if it can help improve PET imaging of solid tumors in patients by looking at how well it targets a specific protein found in those tumors.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | November 30, 2024 |
| Study ends | November 30, 2026 |
| Registry record updated | August 23, 2024 |
| Trial ID | NCT06454955 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 with measurable solid tumors and adequate hematologic and organ function.
✕Probably not a fit
Patients with severe organ dysfunction or those without measurable tumors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of a radioactive probe, [68Ga]B7H3 Affibody-BCH, for PET imaging of solid tumors. It aims to evaluate the radioactive uptake of the probe and its correlation with B7-H3 receptor expression in tumor patients. The research utilizes whole-body PET technology to analyze the pharmacokinetic dynamics of the probe, establishing a framework for pharmacokinetic analysis in this context. The findings could enhance the understanding of tumor biology and improve imaging techniques.
Why it matters
Potential benefit: If successful, this study could lead to improved imaging techniques for better diagnosis and treatment planning in cancer patients.
How similar studies have gone: Other studies using targeted imaging probes have shown promise, suggesting potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age range 18-75 years, open to both male and female participants; 2. Participants must meet the following hematologic and hepatic/renal function criteria: Hematology: WBC ≥ 4.0 × 10\^9/L or neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L; Prothrombin time (PT) or Activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN); Hepatic and renal functions: Total bilirubin (T-Bil) ≤ 1.5 times the upper threshold limit (ULT), ALT/AST ≤ 2.5 ULN or ≤ 5 ULT for subjects with liver metastasis, Alkaline phosphatase (ALP) ≤ 2.5 ULN (or ≤ 4.5 ULN in cases of bone or liver metastasis); Blood urea nitrogen (BUN) ≤ 1.5 × ULT, serum creatinine (SCr) ≤ 1.5 × ULT; 3. Normal cardiac function; 4. Expected survival of at least 12 weeks; 5. Good adherence to follow-up; 6. Presence of at least one measurable target lesion according to RECIST 1.1 criteria; 7. Women of childbearing age (15-49 years) must undergo a pregnancy test within seven days prior to the commencement of the study and test negative; sexually active male and female participants must agree to utilize effective contraception to prevent pregnancy during the study and for three months following the final examination; 8. Patients for whom a clinical physician recommends PET/CT scans for the diagnosis and staging of tumors; 9. Participants must fully understand and voluntarily agree to participate in the study, and must sign an informed consent form. Exclusion Criteria: 1. Severe abnormalities in liver and renal function and blood counts; 2. Patients planning to conceive; 3. Pregnant or lactating women; 4. Individuals unable to lie flat for thirty minutes; 5. Individuals who refuse to participate in this clinical study; 6. Individuals suffering from claustrophobia or other psychiatric disorders; 7. Other situations deemed unsuitable for trial participation by the researchers.
Where it's running
-
Xiangxi Meng
Beijing, Beijing Municipality, China Recruiting
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.