Clinical trial · Interventional
Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases
Pilot Study of Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI changed institutions
Summary
Brief summary (as posted)
This study aims to determine the feasibility of non-invasive quantitative PD-L1 measurement using \[a novel PD-L1 positron emission tomography (PET) tracer and perform immunohistochemistry based measurement of PD-L1 levels within resected lesions in head and neck cancer and brain metastases.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Head Neck | — | UNRESOLVED | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adnectin 18F-BMS-986192 Brain Metastases | Drug | — | UNRESOLVED |
| adnectin 18F-BMS-986192 Head and Neck Cancer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Head and neck cancer
- description
- Participants with head and neck squamous cell carcinoma who plan to undergo tumor resection and lymph node resection.
- interventionNames
- Drug: adnectin 18F-BMS-986192 Head and Neck Cancer
- type
- EXPERIMENTAL
- label
- Brain Metastases
- description
- Participants with metastases to the brain from melanoma, lung cancer, breast cancer.
- interventionNames
- Drug: adnectin 18F-BMS-986192 Brain Metastases
Primary outcomes (1)
- measure
- Non-invasive quantitative PD-L1 levels will be measured using PET measures (VT) of lesions for the groups of PD-L1 levels (PD-L1 ≥90% vs <1%, PD-L1 ≥50% vs <1%) in head and neck cancer primary lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for Head and Neck Cancer: * Patients with resectable squamous cell carcinoma of the oropharynx (HPV positive and HPV negative). * Resectability will be confirmed by a surgical co-investigator. * If available, HPV-association determined by institutional p16 testing (CINtec antibody demonstrating strong and diffuse nuclear and cytoplasmic staining is at least 70% of cells). * Absolute neutrophil count (ANC) \> 1500/microliter, absolute lymphocyte count (ALC) \>1000/microliter, hemoglobin \> 9 g/dl, platelets \> 100,000/microliter. * aspartate aminotransferase (AST) and alanine transaminase (ALT) \< 5 x upper limit of normal. Bilirubin \< 1.5 x upper limit of normal. * Albumin \> 0 g/dl. * Creatinine \< 5 x upper limit of normal. * Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to treatment Inclusion Criteria for Brain Metastases: * Patients with brain metastases * Tumor size equal or greater than 1 cm * Resectability or need for laser interstitial thermal therapy (LITT) will be confirmed by a surgical co-investigator. * Absolute neutrophil count (ANC) \> 1500/microliter, absolute lymphocyte count (ALC) \>1000/microliter, hemoglobin \> 9 g/dl, platelets \> 100,000/microliter * AST and ALT \< 5 x upper limit of normal. Bilirubin \< 1.5 x upper limit of normal. * Albumin \> 0 g/dl. * Creatinine \< 5 x upper limit of normal. * Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to treatment Exclusion Criteria for Head and Neck Cancer: * Medical contraindication to surgery. * Full dose anticoagulation. * Concomitant invasive malignancy, or malignancy within 2 years except for hormonally responsive breast or prostate cancer, resected non-melanoma skin cancer, resected uterine cervical carcinoma. * Inability to give informed consent. * Prior systemic therapy, radiation or gross resection for the tumor under study. * Women may not be pregnant or breast-feeding. * Receipt of other systemic therapy including investigational agents, radiation or gross resection for treatment of the tumor under study. Exclusion Criteria for Brain Metastases: * Medical contraindication to brain surgery. * Full dose anticoagulation. * Inability to give informed consent. * Women may not be pregnant or breast-feeding.
References
Publications (0)
Data not yet available