Using a new imaging probe to detect tumor markers in solid tumors
A First-in-human, Non-randomised, Single-arm Pilot and Feasibility Study of [68Ga]Ga-THP-PDL1-3 PET/CT in Patients With Solid Tumors
NA · Peking University Cancer Hospital & Institute · NCT06383598
This study is testing a new imaging tool to see if it can help find specific markers in solid tumors for patients who might benefit from anti-PD-L1 treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06383598 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a noninvasive PET/CT imaging technique using the 68Ga-THP-PD-L1-3 probe to detect PD-L1 expression in patients with solid tumors. The approach involves recruiting participants to assess the pharmacokinetics, safety, and tumor targeting of the imaging probe. Initially, 10 participants will be analyzed for organ distribution and tumor uptake, followed by a larger group of 20-30 participants for in vivo safety evaluations. The final analysis will summarize the findings from all participants to determine the probe's effectiveness in identifying candidates for anti-PD-L1 treatment.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with solid tumors or suspected tumor lesions and a life expectancy of at least 12 weeks.
Not a fit: Patients with significant hepatic or renal dysfunction, those who are pregnant, or individuals unable to remain still for the imaging procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging technique could help identify patients who are most likely to benefit from anti-PD-L1 therapies.
How similar studies have performed: While this approach is innovative, similar studies using PET imaging for tumor marker detection have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-70 years, ECOG score 0 or 1; 2. Patients with solid tumors; 3. Presence of measurable lesions on imaging examinations; 4. Expected survival ≥12 weeks. Exclusion Criteria: 1. Severe hepatic or renal dysfunction; 2. Women who are planning pregnancy, pregnant, or breastfeeding; 3. Unable to remain in supine position for 30 minutes; 4. Refusal to participate in this clinical study; 5. Diagnosis of claustrophobia or other psychiatric disorders; 6. Other conditions deemed by the investigator as inappropriate for participation in the trial.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Hua Zhu — Peking University Cancer Hospital & Institute
- Study coordinator: Hua Zhu
- Email: zhuhuabch@pku.edu.cn
- Phone: 010-88196495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumor