NCT03908684

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 320 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Prostate Cancer
• Head and Neck Cancer
• Rectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-12-17
• Primary completion: 2025-12-17
• Completion: 2029-12-17
• First posted: 2019-04-09
• Last updated: 2023-12-13

Locations

1 site across 1 country: Canada