An observational study in Prostate Cancer, Head and Neck Cancer and Rectal Cancer, sponsored by Sunnybrook Health Sciences Centre. Recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by Sunnybrook Health Sciences Centre · Observational
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
The purpose of the study is to test the hypothesis that ultrasound imaging and spectroscopy may be used as a predictive marker of advanced tumour response to radiotherapy. The main goal is to select the best ultrasound ultrasound spectroscopy parameter and vascular distribution index to use as an early predictor of pathological complete or partial response as a primary endpoint. Tumour size decrease as a secondary endpoint. Other secondary endpoints will include measuring changes in blood vessel distribution with treatment and changes in ultrasound parameters will be correlated with two and five year survival rates. Finally, we will investigate if prostate masses can be characterized (benign vs. malignant) using ultrasound backscatter parameters.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's planned enrollment of 320 is above the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men and women who are receiving radiotherapy for head and neck cancer, or rectal cancer, and men who are receiving radiotherapy for prostate cancer
(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
Exclusion Criteria:
(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
The research will involve a clinical evaluation consisting of 200 patients in the head and neck cohort. It will assess changes in five different ultrasound spectroscopic parameters over different times during treatment with radiotherapy as predictors of tumour shrinkage and pathologic complete response. Ultrasound parameters investigated will include mid-band fit (related to image intensity), spectroscopic slope (backscatter versus frequency), spectroscopic intercept, histogram fit size and shape parameters which can be used as estimates of scatterer size and concentration.
Device: Ultrasound Imaging
The research will involve a clinical evaluation consisting of 100 patients in the prostate cohort. It will assess changes in five different ultrasound spectroscopic parameters over different times during treatment with radiotherapy as predictors of tumour shrinkage and pathologic complete response. Ultrasound parameters investigated will include mid-band fit (related to image intensity), spectroscopic slope (backscatter versus frequency), spectroscopic intercept, histogram fit size and shape parameters which can be used as estimates of scatterer size and concentration.
Device: Ultrasound Imaging
The research will involve a clinical evaluation consisting of 20 patients in the rectal cohort. It will assess changes in five different ultrasound spectroscopic parameters over different times during treatment with radiotherapy as predictors of tumour shrinkage and pathologic complete response. Ultrasound parameters investigated will include mid-band fit (related to image intensity), spectroscopic slope (backscatter versus frequency), spectroscopic intercept, histogram fit size and shape parameters which can be used as estimates of scatterer size and concentration.
Device: Ultrasound Imaging
Ultrasound Spectroscopy assess changes in five different ultrasound spectroscopic parameters over different times during treatment with radiotherapy as predictors of tumour shrinkage and pathologic complete response. Ultrasound parameters investigated will include mid-band fit (related to image intensity),spectroscopic slope (backscatter versus frequency), spectroscopic intercept, histogram fit size and shape parameters which can be used as estimates of scatterer size and concentration.
Also known as: Ultrasound Spectroscopy
Radiation Treatment Response
Evaluate tumour response to radiotherapy as measured radiologically within the treated therapeutic region.
Time frame: Up to 5 years
Radiation Treatment Long-term Clinical Outcome
Evaluating tumour response to radiotherapy as measured radiologically within the treated therapeutic region and assessing long-term clinical outcomes.
Time frame: Up to 5 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sunnybrook Health Sciences Centre