Using ultrasound spectroscopy to predict radiation treatment response in cancer patients
Pilot Investigation of Ultrasound Cell Death Imaging and Spectroscopy as Early Indicators of Response to Radiation Treatment in Prostate, Rectum and Head and Neck Cancers, and to Characterize Prostate Masses
This study is testing if special ultrasound techniques can help predict how well radiation treatment works for patients with prostate, rectal, and head and neck cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03908684 on ClinicalTrials.gov |
What this trial studies
This study aims to identify optimal ultrasound spectroscopy parameters that can serve as early indicators of treatment response in patients with prostate, rectal, and head and neck cancers undergoing radiotherapy. By utilizing high-frequency and conventional-frequency ultrasound techniques, the researchers will assess various forms of cell death and correlate ultrasound parameters with tumor response and survival rates. The primary endpoint is to determine the best ultrasound spectroscopy parameter for predicting pathological complete or partial response, while secondary endpoints include tumor size reduction and changes in blood vessel distribution.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed prostate, rectal, or head and neck cancers who have not yet received first-line therapy and are scheduled for radiation treatment.
Not a fit: Patients with prior treatment for their cancers or those with non-measurable disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enable earlier and more accurate predictions of treatment response, potentially improving patient outcomes.
How similar studies have performed: While the use of ultrasound spectroscopy in this context is innovative, previous studies have shown promise in detecting cell death using ultrasound techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) Histologically or cytologically confirmed prostate, rectum and head and neck carcinoma which has not been treated with any first-line therapy and will be treated with radiation therapy * (2) Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment * (3) Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1 * (4) Life expectancy of at least 6 months * (5) Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing: (i) hemoglobin \>90 mg/dL (ii) leukocytes \>3,000/mL (iii) absolute neutrophil count \>1,500/mL (iv) platelets \>100,000/mL (v) total bilirubin within normal institutional limits (vi) AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal (vii) 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 * (6) Patients should have the ability to understand and the willingness to sign a written informed consent document. Signed informed consent must be obtained prior to any study specific procedures Exclusion Criteria: * (1) 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 * (2) Receiving any other investigational agents * (3) Known brain metastases * (4) History of allergic reactions attributed to compounds of similar chemical or biologic composition * (5) Contraindications to radiotherapy such as but not limited to: (i) previous radiotherapy to an involved area (ii) active collagen vascular disease (iii) genetic diseases associated with hyper-radiosensitivity * (6) Any clinically serious infections requiring systemic anti-bacterial, antifungal or antiviral therapy * (7) Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia * (8) Psychiatric illness/social situations that would limit compliance with study requirements * (9) History of active ongoing seizure disorder, substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * (10) 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 Czarnota, PhD, MD — Sunnybrook Health Sciences Centre
- Study coordinator: Gregory J Czarnota, PhD, MD
- Email: gregory.czarnota@sunnybrook.ca
- Phone: (416) 480-6128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.