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

NCT04140513 | Withdrawn DMC FDA Device

• 2 other identifiers: OSU-19172NCI-2019-05315
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• Quantitative assessments of digital positron emission tomography (dPET) characteristics generated at early time points during treatment

  For each of the promising dPET parameters identified in the primary analysis we will examine potential cut-points to be used to best predict 6-month response/non-response using receiver operating characteristic (ROC) methods. Here we will examine specificity, sensitivity, positive predictive value and negative predictive values for each promising parameter to allow for preliminary data to be generated to anticipate which parameters may warrant future study.

  Up to 2 years

Secondary Outcomes (6)

• Tumor burden

  Up to 2 years

• Response rate for each patient local control

  At 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Standard uptake volume (SUV) from digital/conventional PET

  At 3 months

• Metabolic tumor volume (MTV) from digital/conventional PET

  At 3 months

Study Arms (1)

Diagnostic (dPET)

EXPERIMENTAL

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.

Radiation: Fludeoxyglucose F-18; Procedure: Positron Emission Tomography

Interventions

Fludeoxyglucose F-18 RADIATION

Given via injection

Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Diagnostic (dPET)

Positron Emission Tomography PROCEDURE

Undergo dPET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Diagnostic (dPET)

Eligibility Criteria

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

You may qualify if:

• Patient who will undergo definitive radiation with concurrent chemotherapy with cisplatin 40 mg/m\^2 weekly (preferred) or high dose cisplatin 100 mg/m\^2 for histologically confirmed locally advanced squamous cell carcinoma of the oropharynx
• Patient must have clinically or radiographically evident measurable disease at the primary site and at nodal station(s). Tonsillectomy or local excision of the primary or nodal disease is not permitted
• p16 and/or human papillomavirus (HPV) status obtained on biopsy specimen (archival or fresh)
• Patients must provide their personal smoking history prior to registration
• Patients must fall into one of the following stage (American Joint Committee on Cancer \[AJCC\] 8) and risk groups based on pre-treatment work-up and smoking history:
• Low risk classification:
• p16 and/or HPV positive, T1-3, N1-2, M0 with =\< 10 pack years smoking history OR
• Intermediate risk classification:
• p16 and/or HPV positive, T4, N3, M0 and/or HPV positive with \> 10 pack year smoking history
• HPV negative, T1-3, N1-2b, M0, with =\< 10 pack years smoking history OR
• High risk classification:
• p16 and/or HPV negative, T4, N3, M0
• p16 and/or HPV negative with \> 10 pack year smoking history
• Patients with no contraindications to PET imaging or cisplatin
• No prior history of radiation therapy

You may not qualify if:

• Prior cancers except non-melanoma skin cancer outside of the head and neck unless disease free for 5 years
• Carcinoma of unknown primary, even if p16 positive
• Clinical or radiologic evidence of metastatic disease as defined by disease below the clavicles
• Simultaneous primary cancers or separate bilateral primary tumor sites with the exception of patients with bilateral tonsil cancers
• Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Medical contraindications to PET imaging (e.g. pregnancy, nursing mothers, weight greater than 420 pounds)
• Medical contraindications to cisplatin or prior allergic reaction to cisplatin
• Subjects who are unable to receive intravenous contrast due to a contrast allergy or poor renal function
• Subjects who are prisoners
• Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject?s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator. This could include severe, active co-morbidities such as:
• Uncontrolled cardiac disease (hypertension, unstable angina, myocardial infarction within last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction)
• Uncontrolled diabetes
• Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Carcinoma

Interventions

Fluorodeoxyglucose F18; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Eric D Miller

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

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: October 24, 2019
• First Posted: October 28, 2019
• Study Start: October 9, 2020
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)