Evaluating Photoacoustic Imaging for Head and Neck Cancer

Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer

This study is testing a new imaging technique to see how head and neck cancer patients' lymph nodes change during their treatment with radiation, with or without chemotherapy.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT04428515 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess the changes in lymph node involvement in patients with head and neck cancer during their radiotherapy treatment, with or without chemotherapy, using photoacoustic (PA) imaging. Up to 50 participants will be recruited and imaged five times over the course of their treatment, which lasts up to seven weeks. The study will correlate changes in PA imaging parameters with radiological responses assessed via MRI 10 to 12 weeks post-treatment. The goal is to enhance understanding of treatment responses through innovative imaging techniques.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed head and neck carcinoma who have not received prior treatment and are scheduled for radiotherapy.

Not a fit: Patients with previously treated head and neck cancer or those with non-measurable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the monitoring of treatment responses in head and neck cancer, leading to better patient outcomes.

How similar studies have performed: While the use of photoacoustic imaging is a novel approach in this context, similar imaging techniques have shown promise in other studies for monitoring cancer treatment responses.

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

Where this trial is running

Toronto, Ontario

• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Gregory J Czarnota, PhD, MD — Sunnybrook Health Sciences Centre

Conditions: Head and Neck Cancer, Photoacoustic, Head and Neck, Radiotherapy