Clinical trial NCT04428515: Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer
Official title: Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Keywords: Photoacoustic
Head and Neck
Radiotherapy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men or women with confirmed head and neck carcinoma and will be treated with radiotherapy.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed head and neck carcinoma which has not been treated with any first-line therapy and will be treated with radiotherapy
* Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment
* Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of at least 6 months
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:

  1. hemoglobin \>90 mg/dL
  2. leukocytes \>3,000/mL
  3. absolute neutrophil count \>1,500/mL
  4. platelets \>100,000/mL
  5. total bilirubin within normal institutional limits
  6. AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
  7. creatinine within normal institutional limits or creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal
* Subjects must give appropriate written informed consent prior to participation in the study;
* Subjects must be able and willing to comply with the safety procedures during the Scanning Period;

Exclusion Criteria:

* Chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration
* Receiving any other investigational agents
* Known brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition
* Contraindications to radiotherapy such as but not limited to:

  1. previous radiotherapy to an involved area
  2. active collagen vascular disease
  3. genetic diseases associated with hyper-radiosensitivity
* Any clinically serious infections requiring systemic anti-bacterial, antifungal or antiviral therapy
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection,
* Symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
* History of active ongoing seizure disorder
* Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study

Primary outcomes:
measure: Correlation of response to treatment between photoacoustic parameters and final radiological outcome. measures of outcome.
timeFrame: 3 months
Secondary outcomes:
measure: Correlation between photoacoustic parameters and five-year overall survival.
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Gregory J Czarnota, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: