NCT04140513

Digital PET Scan for the Prediction of Outcomes in Patients With Locally Advanced Oropharyngeal Cancer

A Pilot Study to Evaluate the Utility of Interim Digital PET/CT in Predicting Outcomes for Locally Advanced Oropharyngeal Cancer

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well digital PET scan works in predicting outcomes in patients with oropharyngeal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). The development of digital detectors for PET is a technological improvement in medical imaging that could potentially impact many areas of clinical oncology, including staging, radiation planning accuracy, and the assessment of treatment response. Digital technology may improve PET imaging performance by providing better timing, energy and spatial resolution, higher count rate capabilities and linearity, increased contrast, and reduced noise. Utilizing digital PET scan, may work better in predicting outcomes and treatment response in patients with oropharyngeal cancer compared to conventional PET.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the utility of early (i.e. during treatment) digital positron emission tomography (dPET) as a diagnostic tool to predict local control 6 months after definitive chemoradiation for patients with locally advanced oropharyngeal carcinoma. SECONDARY OBJECTIVES: I. To study the association between dynamic dPET parameters taken at early time points (i.e. during treatment) and CR on PET after definitive chemoradiation. II. To study the association between dynamic dPET parameters taken at early time points (i.e. during) treatment and 2 year local control after definitive chemoradiation. III. To assess the ability of dynamic dPET compared to conventional PET or conventional-equivalent dPET reconstruction to identify tumor volumes with greater sensitivity at the time of before (dPET1), during (dPET2, dPET3) and after (dPET4, dPET5) chemoradiation. IV. To generate preliminary data for future methodology or clinical trials. OUTLINE: Patients receive fludeoxyglucose F-18 via injection and undergo dPET over 20 minutes after standard of care computed tomography (CT) imaging (week -2), after receiving 20-26 Gy and 40-46 Gy of radiation (weeks 3 and 5), and 3 months after completion of treatment. Patients with concern for residual disease may receive an additional dPET 6 months after treatment.

Conditions

• Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Locally Advanced Oropharyngeal Squamous Cell Carcinoma
• Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Interventions

Type	Name	Description
RADIATION	Fludeoxyglucose F-18	Given via injection
PROCEDURE	Positron Emission Tomography	Undergo dPET

Timeline

• Start date: 2020-10-09
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2019-10-28
• Last updated: 2024-03-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study