Imaging solid tumors using a targeted radioactive probe

Study of B7-H3 Mediated Tumor Immune Response Using a Whole-Body Kinetic Approach in Whole-Body PET

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_PHASE1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06454955 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with measurable solid tumors and adequate hematologic and organ function.

Not a fit: Patients with severe organ dysfunction or those without measurable tumors may not benefit from this study.

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 performed: Other studies using targeted imaging probes have shown promise, suggesting potential success for this novel approach.

Eligibility 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 this trial is running

Beijing, Beijing Municipality

• Xiangxi Meng — Beijing, Beijing Municipality, China (RECRUITING)

Conditions: B7H3, CD276 Affibody, PET/CT Imaing