Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma HNSCC, Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)
Conditions
Keywords
Head and neck cancer, P16+ and P16-, PET, CCR2
Brief summary
This is a prospective study to evaluate the sensitivity and specificity of Cu-64 DOTA-ECL1i PET/CT imaging to serve as a novel precision imaging tool for patients with head and neck squamous cell carcinoma (HNSCC).
Interventions
DRUG64Cu-DOTA-ECL1i
64Cu-DOTA-ECL1i a novel PET imaging tracer that will be provided intravenously (IV) while participants will be positioned supine on the on the scanning table. The injection will be followed with saline flush.
Sponsors
Washington University School of Medicine
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient 18 years of age or older * Cohort 1: Newly diagnosed locally advanced T3-T4a, N0-3 and M0 squamous cell head and neck cancer scheduled to undergo standard of care surgery with or without neoadjuvant therapy OR Cohort 2: Suspected or biopsy proven recurrent/metastatic squamous cell head and neck cancer scheduled to undergo first-line anti-PD1 therapy. HPV status does not need to be known and both HPV+ and HPV- subjects are eligible to enroll * Lesion size of at least 1.0 cm in longest dimension by conventional imaging. * Able to give informed consent * Not currently pregnant or nursing: Female subjects must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post- menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of Cu-DOTA-ECL1i is negative
Exclusion criteria
* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 2 years * Unable to tolerate approximately 60 min (total time) of PET/CT imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1 only: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake | At baseline prior to scheduled surgery (estimated time frame: 1 day) | 64Cu-DOTA-ECL1i PET uptake will be assessed using standardized update value maximum (SUVmax). SUV is a decay-corrected measurement of activity per volume of tissue (µCi/mL) divided by the average activity per unit mass in the entire body and/or tumor-to-normal-tissue-ratio. SUVmax is the highest measured uptake of a tracer of a lesion on a PET scan. |
| Cohort 1 only: Quantitative 64Cu-DOTA-ECL1i PET/CT uptake | At time of surgery (total estimated time up to 14 days) | Quantitative 64Cu-DOTA-ECL1i PET uptake will be assessed via a Logan/Patlak analysis to characterize the pharmacokinetics of the tumor. Logan/Patlak is a graphical analysis which uses linear regression to analyze the pharmacokinetics of tracers involving reversible uptake. |
| Cohort 2 only: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake | At baseline (estimated time frame: 1 day) | 64Cu-DOTA-ECL1i PET uptake will be assessed using standardized update value maximum (SUVmax). SUV is a decay-corrected measurement of activity per volume of tissue (µCi/mL) divided by the average activity per unit mass in the entire body) and/or tumor-to-normal-tissue-ratio. SUVmax is the highest measured uptake of a tracer of a lesion on a PET scan |
| Cohort 2 only: Quantitative 64Cu-DOTA-ECL1i PET/CT uptake | At time of surgery (total estimated time up to 14 days) | Quantitative 64Cu-DOTA-ECL1i PET uptake will be assessed via a Logan/Patlak analysis to characterize the pharmacokinetics of the tumor. Logan/Patlak is a graphical analysis which uses linear regression to analyze the pharmacokinetics of tracers involving reversible uptake. |
| Cohort 1 only: CCR2 expression in tumor tissue | At time of surgery (total estimated time up to 14 days) | CCR2 expression will be analyzed in tumor tissue specimens obtained from surgical specimens collected at resection and from archival biopsy specimens obtained prior to neoadjuvant therapy. CCR2 expression will be examined using flow cytometry and RT-PCR. |
| Cohort 2 only: Change in 64Cu-DOTA-ECL1i PET uptake from baseline to post-cycle 3 imaging | At baseline and post cycle 3 imaging (estimated time frame up to 9 weeks) | 64Cu-DOTA-ECL1i PET uptake will be assessed using standardized update value maximum (SUVmax). SUV is a decay-corrected measurement of activity per volume of tissue (µCi/mL) divided by the average activity per unit mass in the entire body and/or tumor-to-normal-tissue-ratio. SUVmax is the highest measured uptake of a tracer of a lesion on a PET scan. |
| Cohort 2 only: Objective response | Enrollment until date of completion of follow-up, date of disease progression, or time of death, whichever occurs first (estimated total time to be 12 months) | Objective response will be assessed according to RECIST 1.1. Objective response is defined as categorized as responder versus non-responder based on best overall response. Responder is defined as best overall response as complete or partial response. Non-responder is defined as best overall response as stable disease or progressive disease. |
| Cohort 2 only: Progression-free survival (PFS) | Start of anti-PD1 treatment to date of disease progression or death from any cause (total estimated time to be 12 months) | PFS is defined from anti-PD1 treatment start date to date of progression or date of death due to any cause. PFS will be analyzed by the Kaplan-Meier method. |
| Cohort 2 only: Overall survival (OS) | Start of anti-PD1 treatment to date of death from any cause (total estimated time to be 12 months) | OS is defined from start of treatment to death due to any cause or last date of follow up. Alive patients are censored at the last follow-up otherwise. OS will be analyzed by the Kaplan-Meier method. |
Countries
United States
Contacts
CONTACTFarrokh Dehdashti, MD
PRINCIPAL_INVESTIGATORFarrokh Dehdashti, MD
Washington University School of Medicine
Outcome results
None listed