Status:
TERMINATED
Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer Head Neck
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 measu...
Detailed Description
This study aims to validate a non-invasive quantitative imaging method of whole tumors using a novel PD-L1 positron emission tomography (PET) tracer in patients with head and neck cancer who undergo r...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05408871
Start Date
February 21 2023
End Date
January 31 2024
Last Update
February 15 2024
Active Locations (1)
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1
Yale University PET Center
New Haven, Connecticut, United States, 06519