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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

HPV- negative OPSCC

Presence of distant metastatic (M1) disease

Pregnancy

Existence of significant co-morbidities at baseline which would prevent standard CRT treatment

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: HPV Positive Oropharyngeal Squamous Cell CarcinomaOther 1 intervention

Trial outcomes

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).

Time frame
1 Year

Secondary outcomes

1

Secondary Outcome

Development of a Bayesian Network-based prediction model in identifying good responders to standard Chemo-Radiotherapy (CRT).

Time frame
1 year

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: