NCT04428515

Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

In this study, PA imaging will be used to examine the physiological and physical changes in lymph node involvements of head and neck cancer during radiotherapy with or without chemotherapy. Our objective in this pilot study will be to evaluate if PA parameters change within the lymph node involvements during chemoradiation therapy over time. Our hope is to use this information to correlate the changes in measured PA parameters with radiological response.

Detailed description

A trained clinical research coordinator will evaluate and authorize that each screened volunteer is a suitable subject for the study prior to enrolment. Written informed consent will be obtained from each participant prior to any clinical research scans to be performed on the subject. Those subjects who qualify will have their lymph node imaged using a PA imaging system. Up to 50 subjects will be recruited for this study. Participants will be imaged 5 times over the course of radiotherapy regimen, which span up to 7 weeks. The patients will be assessed with MRI 10 to 12 weeks after the completion of Chemoradiation therapy as per the institution's standard of care. The lymph nodes will be measured by a staff radiologist, and the sizing information will be used to categorize patients into responders or non-responders. This information will be accessed using the patient's electronic medical record. Each patient will be assigned an anonymized accession number to the study that withholds any identifiers. There will be a complete accounting of all missing and excluded data, if any. Although we do not anticipate any adverse events, all AEs will be documented in the CRF, and will be immediately reported to the REB, the overseeing physician responsible for the patient's care, and the study principal investigators. Descriptive statistics (arithmetic mean, standard deviation, and coefficient of variation) and tabulation (stem and leaf plots) of study endpoints (absolute values and absolute value/comparator differences) will be used. PA datasets will be tested for normality, using a Shapiro-Wilk test (alpha=0.05). Comparative tests will use an independent t-test (or Mann Whitney test for normality violations) to compare the PA measurements between different breast masses (fibroadenomas, cysts, tumors). In determining chemoradiation therapy evaluation, the primary endpoint, multiple linear regression models to relate study endpoints to subject characteristics and a logistic regression model will be used to build for multiparametric analysis of multiple PA parameters as a predictive model to pathological response. Descriptive statistics (frequency per scan, frequency per subject) and tabulation will be used to analyze the frequency of system malfunction. Overall Survival Evaluation, the secondary endpoint, will use linear discriminant analysis to test for sensitivity, specificity and accuracy of the PA parameters as a diagnostic test. Receiver-operating characteristic will be used to test for PA cutoff values and a logistic regression model will be used to build for multiparametric analysis of multiple PA parameters as a predictive model to pathological response.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DEVICE	Photoacoustic Imaging System	Photoacoustic Imaging investigate changes of measured PA markers and compare these to radiological assessment of response of lymph node involvement to chemoradiation therapy for head and neck cancer

Timeline

• Start date: 2019-04-23
• Primary completion: 2024-04-23
• Completion: 2027-04-23
• First posted: 2020-06-11
• Last updated: 2023-12-13

Locations

1 site across 1 country: Canada