Ultrasound to spot early radiation response in prostate and other cancers
Studies ultrasound to spot early radiation response in several cancers.
Plain-language title generated from the registry record
Registry title: Ultrasound Spectroscopy as Early Indicators of Radiation Treatment Response in Prostate, Rectum and Head & Neck Cancers
Key facts
- Where
- Toronto, CanadaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with prostate, rectal, or head and neck cancer who have not had any first-line treatment and will get radiation therapy. It uses ultrasound to watch how the cancer responds.
- Sex
- Men and women can join.
- Disease stage
- Prostate, rectal, or head and neck cancer confirmed by tissue or cell tests, with disease that can be measured by ultrasound or MRI within 28 days before treatment.
- Earlier treatment
- No first-line therapy before. No chemotherapy, radiotherapy or major surgery within 4 weeks before joining.
Main reasons for not taking part
- Known brain metastases
- Other investigational agents being taken
- Previous radiotherapy to the involved area
- Serious infection needing systemic anti-bacterial, antifungal or antiviral treatment
- Uncontrolled illness such as heart failure, unstable angina or cardiac arrhythmia
Read by machine on 9 November 2026.
Where in Canada
- Sunnybrook Health Sciences CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sunnybrook Health Sciences Centre
- Trial code
- NCT03908684
- Record updated
- 13 December 2023
- Original description
Our objective in this study is to identify an optimal ultrasound spectroscopy parameter that can be used as an early predictor of pathological complete or partial response in men with prostate cancer and men and women with rectum and head and neck cancers receiving treatment radiotherapy.Read full original descriptionShow less
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
Our objective in this study is to identify an optimal ultrasound spectroscopy parameter that can be used as an early predictor of pathological complete or partial response in men with prostate cancer and men and women with rectum and head and neck cancers receiving treatment radiotherapy.
We have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. The method can detect different forms of cell death and has been demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. The main goal, as described above, is to select the best ultrasound spectroscopy parameter to use as an early predictor of pathological complete response
Inclusion: (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: (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; (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; (4) History of allergic reactions attributed to compounds of similar chemical or biologic composition; (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; (3) Known brain metastases.