Recruiting

Ultrasound Spectroscopy

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT03908684

Conditions

Prostate Cancer

Head and Neck Cancer

Rectal Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Ultrasound Imaging

Study Details

Brief 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

Conditions

Prostate Cancer

Head and Neck Cancer

Rectal Cancer

Study ID

NCT03908684

Start date

Dec 17, 2014

Status verified date

Dec, 2023

Completion date

Dec 17, 2029

Anticipated

Primary completion date

Dec 17, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

320 participants

Anticipated

Interventions and Outcome Measures

Arms

Head and Neck

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.

Prostate

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.

Rectum

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.

Interventions

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.

Primary outcome measure

  • Radiation Treatment Response [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Gregory J Czarnota, PhD, MD

(416) 480-6128gregory.czarnota@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Gregory J Czarnota, PhD, MD

(416) 480-6128gregory.Czarnota@sunnybrook.ca

Principal Investigator:

Gregory J Czarnota, PhD, MD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Dec 13, 2023

Last verified

Dec, 2023

Keywords

  • Ultrasound
  • Spectroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-12-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.