Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer

NCT04428515 | Recruiting

• 1 other identifier: 135-2018
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Photoacoustic; Head and Neck; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Correlation of response to treatment between photoacoustic parameters and final radiological outcome. measures of outcome.

  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.

  3 months

Secondary Outcomes (1)

• Correlation between photoacoustic parameters and five-year overall survival.

  5 years

Study Arms (1)

Radiotherapy Response Monitoring

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

Device: Photoacoustic Imaging System

Interventions

Photoacoustic Imaging System DEVICE

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

Radiotherapy Response Monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men or women with confirmed head and neck carcinoma and will be treated with radiotherapy.

You may qualify if:

• 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:
• hemoglobin \>90 mg/dL
• leukocytes \>3,000/mL
• absolute neutrophil count \>1,500/mL
• platelets \>100,000/mL
• total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
• 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;

You may not qualify if:

• 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:
• previous radiotherapy to an involved area
• active collagen vascular disease
• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Gregory J Czarnota, PhD, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: April 23, 2019
• Primary Completion: April 23, 2024
• Study Completion (Estimated): April 23, 2027
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)