NCT03908684Recruiting
Ultrasound Spectroscopy as Early Indicators of Radiation Treatment Response in Prostate, Rectum and Head & Neck Cancers
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
Source: ClinicalTrials.gov · Last updated 13 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 320 (estimated)
- First submitted
- 8 Apr 2019
- Start date
- 17 Dec 2014
- Primary completion date
- 17 Dec 2025
- Lead sponsor
- Sunnybrook Health Sciences Centre
- NCT number
- NCT03908684
What you commit to
- Study type: Observational
- Planned participants: 320
- From 17 Dec 2014 to the primary completion date, 17 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- (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
Other illness
- (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.
Other
- (3) Known brain metastases
Who the study is looking for
- (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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.