Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck⦠(NCT05408871) | Clinical Trial Compass
TerminatedPhase 1
Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases
Stopped: PI changed institutions
United States7 participantsStarted 2023-02-21
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dayā¦
What they're measuring
1
Non-invasive quantitative PD-L1 levels will be measured using PET measures (VT) of lesions for the groups of PD-L1 levels (PD-L1 ā„90% vs <1%, PD-L1 ā„50% vs <1%) in head and neck cancer primary lesions
Timeframe: from with in 2 weeks perioperative up to postoperative