Clinical trial · Interventional
Prognostic Biomarkers for Patients With Human Papillomavirus (HPV) Positive Oropharyngeal Squamous Cell Carcinoma
Full Exchange Pharmacokinetic Model Analysis of Dynamic Contrast-Enhanced MRI Data for Identification of Vascular Habitats and Evaluation of Treatment Response in Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV | — | UNRESOLVED | — |
| HPV Positive Oropharyngeal Squamous Cell Carcinoma | Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Oropharyngeal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- HPV Positive Oropharyngeal Squamous Cell Carcinoma
- description
- 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.
- interventionNames
- Diagnostic Test: MRI
Primary outcomes (1)
- measure
- Time to Progression
- timeFrame
- 1 Year
- description
- 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).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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