Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Photoacoustic Imaging System

Sanjiv S. Gambhir

The purpose of this study is to image human prostate tissue using a new transrectal photoacoustic imaging probe and correlate this with ultrasound and MRI imaging performed once the specimen has been surgically removed. We hope to see what we can visualize with our device as this has never been done before. Eventually, we hope to use a similar device to image the prostate in men being seen by their doctor for prostate cancer.

In order to need a prostatectomy, patient must be male.

Transrectal Photoacoustic Imaging of the Prostate

Pilot study to better understand the quality of both ultrasound and photo acoustic images that can be obtained using a transrectal instrument. To understand acquisition parameters that help optimize the image quality.

Stanford University

Head and Neck Neoplasms

Those undergoing radiation therapy treatment to their lymph nodes upon diagnosis of head and neck cancer

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

Gregory J Czarnota, PhD, MD

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.

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.

Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer

The primary study endpoint will 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. Changes in PA parameters will be made to a pre-treatment point over the course of treatment.

The secondary study endpoint will correlate changes of measured PA markers to five-year overall survival (OS) of the same patient cohort. The survival status and of the patient cohort will be tracked after the treatment for five years based on the patient information system and follow up surveys if necessary.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transrectal Photoacoustic Imaging of the Prostate	NCT02365883	Prostate Cancer	Photoacoustic I...	18 Years - 80 Years	Stanford University
Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer	NCT04428515	Head and Neck C...	Photoacoustic I...	-	Sunnybrook Health Sciences Centre
Transrectal Photoacoustic Imaging of the Prostate	NCT02365883	Prostate Cancer	Photoacoustic I...	18 Years - 80 Years	Stanford University

Spots Global Cancer Trial Database for photoacoustic imaging system