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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03908684
• Other study ID #: 448-2013
• Status: Recruiting
• Start date: December 17, 2014
• Est. completion date: December 17, 2029

Study information

• Verified date: December 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Gregory J Czarnota, PhD, MD
• Phone: (416) 480-6128
• Email: gregory.czarnota[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 17, 2029
• Est. primary completion date: December 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Prostate Cancer
• Rectal Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation Treatment Response	Evaluate tumour response to radiotherapy as measured radiologically within the treated therapeutic region.	Up to 5 years
Secondary	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.	Up to 5 years