Actively Recruiting

All Genders
NCT03908684

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

Led by Sunnybrook Health Sciences Centre · Updated on 2023-12-13

320

Participants Needed

1

Research Sites

782 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed prostate, rectum, or head and neck carcinoma not previously treated with first-line therapy and planned for radiation therapy
  • Measurable disease by ultrasound or MRI within 28 days before treatment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of at least 6 months
  • Adequate bone marrow, liver, and kidney function based on recent lab tests
  • Ability to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Chemotherapy, radiotherapy, or major surgery within 4 weeks prior to study registration or unresolved adverse events from prior treatments
  • Receiving any other investigational agents
  • Known brain metastases
  • History of allergic reactions to similar compounds
  • Contraindications to radiotherapy, including prior radiotherapy to the area, active collagen vascular disease, or genetic diseases causing hyper-radiosensitivity
  • Serious infections requiring systemic treatment
  • Uncontrolled illness such as active infection, heart failure, unstable angina, or arrhythmia
  • Psychiatric or social conditions limiting study compliance
  • History of active seizure disorder, substance abuse, or other conditions interfering with participation or evaluation
  • Any unstable condition risking patient safety or study compliance

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

G

Gregory J Czarnota, PhD, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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