NCT06690216Enrolling by invitationPhase 1/2
Evaluation of [18F]AlF-NOTA-PCP2 PET/CT for PD-L1 Detection in Malignant Tumors
Evaluation of the Value of [18F]AlF-NOTA-PCP2 PET/CT for PD-L1 Detection in Malignant Tumors
Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This phase I/II clinical trial evaluates the safety, efficacy, and prognostic potential of \[18F\]AlF-NOTA-PCP2 PET/CT imaging in assessing PD-L1 expression in malignant tumors, including glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer. The primary aim is to establish the correlation between \[18F\]AlF-NOTA-PCP2 uptake and PD-L1 expression in tumor tissues, while secondary objectives include evaluating its role in predicting clinical outcomes such as progression-free survival (PFS) and overall survival (OS). By providing a non-invasive, quantitative, and reproducible method for assessing PD-L1, this study aims to refine patient stratification and improve the precision of immunotherapy decision-making.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 13 Nov 2024
- Start date
- 30 Mar 2024
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Man Hu
- NCT number
- NCT06690216
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 100
- From 30 Mar 2024 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Failure to recover from toxic effects or complications of prior interventions (≤ grade 1 or baseline levels, excluding fatigue or hair loss).
- Any arterial thrombotic or embolic events within 6 months before enrollment (e.g., myocardial infarction, cerebrovascular accident, transient ischemic attack).
- Women of childbearing potential without a negative pregnancy test prior to study entry.
Other illness
- Severe or uncontrolled systemic diseases, including:
- Major, symptomatic arrhythmias or significant ECG abnormalities (e.g., complete left bundle branch block, second-degree or higher heart block, or ventricular arrhythmias).
- Unstable angina or congestive heart failure (NYHA class ≥ 2).
- Active or uncontrolled infections requiring systemic treatment.
- Severe psychiatric disorders affecting study participation.
- Known allergy or hypersensitivity to \[18F\]AlF-NOTA-PCP2 or any component of the radiopharmaceutical.
Lab values
- Any medical history, laboratory abnormality, or condition that may:
Other
- Participation in another interventional clinical trial.
- Pregnant or breastfeeding women.
- Interfere with study results.
- Affect patient participation.
- Pose an unacceptable risk as determined by the investigator.
Who the study is looking for
- Signed informed consent obtained.
- Age ≥ 18 years, any gender.
- Pathologically confirmed malignant tumors, including:
- Glioblastoma
- Head and neck squamous cell carcinoma
- Non-small cell lung cancer
- Esophageal cancer
- Detectable PD-L1 expression in tumor tissue (based on immunohistochemistry or biopsy).
- Measurable disease with at least one residual tumor lesion.
- ECOG performance status of 0-1.
- No contraindications to \[18F\]AlF-NOTA-PCP2 PET/CT imaging.
- Willing and able to comply with study procedures and follow-up visits.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.