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Not Yet Recruiting
NCT07797738
Prognostic Biomarkers for Patients With Human Papillomavirus (HPV) Positive Oropharyngeal Squamous Cell Carcinoma
Conditions: Oropharyngeal Squamous Cell Carcinoma (OPSCC), HPV, HPV Positive Oropharyngeal Squamous Cell Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Abramson Cancer Center at Penn Medicine
Location: Hospital of the University of Pennsylvania Philadelphia Pennsylvania
Summary
The purpose of this research study is to investigate the relationship between vascular habitats and treatment response AND to investigate the potential utility of dynamic contrast enhanced (DCE)-MRI derived parameters in predicting treatment response.
This data can be used to assist in the development of a clinical decision support (CDS) tool for risk categorization and individualized decision-making. While "low-risk" patients could benefit from de-escalated radiation therapy, "high-risk" patients could receive early initiation of targeted therapies, or immunotherapies.
Eligibility Criteria
Inclusion Criteria:
* Adult population (≥18 years) of both genders
* Biopsy confirmed diagnosis of OPSCC
* Known HPV status as determined by p16 immunohistochemistry (p16 positivity defined as \>70% of carcinoma cells showing nuclear reactivity) or polymerase chain reaction (PCR) sequencing
* Prior to any treatment except for incisional or excisional biopsies
* T0 to T4, N1 to N3, M0 (American Joint Committee on Cancer, 8th edition)
* A willingness to undergo multiple phlebotomy (blood withdrawal) during standard CRT for liquid biopsy analyses.
Exclusion Criteria:
* HPV- negative OPSCC
* Presence of distant metastatic (M1) disease
* Pregnancy
* Existence of significant co-morbidities at baseline which would prevent standard CRT treatment
* Implanted cardiac pacemaker or defibrillator, programmable shunts, deep brain stimulator, other implanted electronic devices which may be contraindicated for 3T MRI
* Presence of significant hemorrhage in and around the tumor bed that may potentially degrade the image quality
* Significant claustrophobia.
Source: ClinicalTrials.gov (NCT07797738). StuddyBuddy aggregates publicly available trial information.