Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases
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.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Feb 15, 2024 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Yale University
- Interventions being studied
- Drug: adnectin 18F-BMS-986192 Head and Neck Cancer; Drug: adnectin 18F-BMS-986192 Brain Metastases
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Yale University PET CenterNew Haven, Connecticut
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 15, 2024. Always confirm current availability with the study team.