Prognostic Biomarkers for Patients With Human Papillomavirus (HPV) Positive Oropharyngeal Squamous Cell Carcinoma

NCT07797738 | Not Yet Recruiting DMC

• 1 other identifier: 26-0210
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oropharyngeal Squamous Cell Carcinoma (OPSCC); HPV; HPV Positive Oropharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  Determination of the clinical utility of pretreatment Diffusion Weighted Imaging (DWI) and Dynamic Contrast Enhanced-MRI (DCE-MRI) derived parameters in predicting response to standard Chemo-radiotherapy (CRT) in patients with HPV-positive Oropharyngeal Squamous Cell Carcinomas (OPSCC).

  1 Year

Secondary Outcomes (1)

• Secondary Outcome

  1 year

Study Arms (1)

HPV Positive Oropharyngeal Squamous Cell Carcinoma

OTHER

You are being asked to complete two research MRI scans with and without contrast because you have been newly diagnosed HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) and plan to receive chemoradiation therapy (CRT). MRI contrast agents act like a dye to make MRI pictures brighter and easier to read. During each MRI scan, you will have an intravenous line (IV line) placed. The IV line allows the contrast agent to be injected into your vein.

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Magnetic Resonance Imaging (MRI) is a type of scan that uses radio waves to take detailed pictures of the body. You will be asked to lie on an MRI table where the technologist will place a receiver on the part of your body to be studied. You will be provided a blanket for comfort and earplugs since the MRI makes noises while it is scanning. You will still be able to hear some sound to ensure you can communicate with the technologist and can follow any direction given throughout the MRI scan. The technologist will slowly slide you into the MRI magnet where radio waves will be transmitted into you.

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Sanjeev Chawla

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marisa Sanchez, Bachelor of Science

CONTACT

215-901-9994; marisa.sanchez@pennmedicine.upenn.edu

Lisa Desiderio

CONTACT

610-721-3365; lisa.desiderio@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: September 1, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): September 15, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)