Head and Neck CancerNCT04428515
Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer
An observational study of Head and Neck Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Photoacoustic Imaging System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 23 Apr 2019to 23 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men or women with confirmed head and neck carcinoma and will be treated with radiotherapy.
Who may be able to join
- 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
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- 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;
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Gregory J Czarnota, PhD, MD, (416)480-6128, gregory.czarnota@sunnybrook.ca
About this study
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.
Read the 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
- Being tested
- Photoacoustic Imaging System
- Keywords
- Photoacoustic, Head and Neck, Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoacoustic Imaging SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy Response Monitoring | Those undergoing radiation therapy treatment to their lymph nodes upon diagnosis of head and neck cancer Receives: Device: Photoacoustic Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Correlation between photoacoustic parameters and five-year overall survival.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start23 Apr 2019
- Primary completion23 Apr 2024 (estimated)
- Study completion23 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre
- Investigators
- Gregory J Czarnota, PhD, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428515
- Sponsor's protocol ID
- 135-2018
- Status last verified
- Dec 2023
- First submitted
- 9 Jun 2020
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04428515
- Acronym / sponsor ID
- 135-2018
- Conditions
- Head and Neck Cancer
- Keywords
- Photoacoustic, Head and Neck, Radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 23 Apr 2024 (estimated)
- Study completion
- 23 Apr 2027 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy Response Monitoring | – | Device: Photoacoustic Imaging SystemThose undergoing radiation therapy treatment to their lymph nodes upon diagnosis of head and neck cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men or women with confirmed head and neck carcinoma and will be treated with radiotherapy.
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photoacoustic Imaging SystemPhotoacoustic 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 | Device | Radiotherapy Response Monitoring |
Primary outcome
Correlation of response to treatment between photoacoustic parameters and final radiological outcome. measures of outcome.
Time frame: 3 months
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.
1 secondary outcome
Correlation between photoacoustic parameters and five-year overall survival.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory J Czarnota, PhD, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of response to treatment between photoacoustic parameters and final radiological outcome. measures of outcome. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023; AzTrials last refreshed its copy on 4 Nov 2026.