Ultrasound Spectroscopy as Indicators of Radiation Treatment Response in Prostate Rectum and Head & Neck Cancers

  • STATUS
    Recruiting
  • End date
    Dec 17, 2024
  • participants needed
    260
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 26 January 2021
renal function
measurable disease
carcinoma
neutrophil count
head and neck carcinoma

Summary

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 objectives of this study are to evaluate the use of ultrasound imaging and spectroscopy as a predictive marker of advanced tumour response to radiotherapy. Since radiation treatments may also act on tumour vasculature to "normalize" it we will also evaluate blood-vessel imaging by standard Doppler-imaging and with standard higher-resolution imaging using clinically approved microbubble contrast agents.

The main goal, as described above, is to select the best ultrasound spectroscopy parameter to use as an early predictor of pathological complete response

Details
Condition Malignant neoplasm of prostate, Prostate Cancer, Prostate Cancer, Early, Recurrent, Colorectal Cancer, Colorectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, Rectal Cancer, Rectal Cancer, Prostatic disorder, Prostate Disorders, head and neck cancer, head and neck cancer, Prostate Disorders, Colon Cancer Screening, Prostate Cancer, Early, Recurrent, Colon cancer; rectal cancer, Prostate Cancer, prostate carcinoma, cancer of the head and neck, prostate cancers, rectal carcinoma
Treatment Imaging
Clinical Study IdentifierNCT03908684
SponsorSunnybrook Health Sciences Centre
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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