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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908684
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre

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 objectives of this study are to evaluate the use of ultrasound imaging and spectroscopy as a predictive marker of advanced tumour response to radiotherapy. Since radiation treatments may also act on tumour vasculature to "normalize" it we will also evaluate blood-vessel imaging by standard Doppler-imaging and with standard higher-resolution imaging using clinically approved microbubble contrast agents.

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


Condition or disease Intervention/treatment
Prostate Cancer Head and Neck Cancer Rectal Cancer Other: Imaging

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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : December 17, 2014
Estimated Primary Completion Date : December 17, 2022
Estimated Study Completion Date : December 17, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Head and Neck Other: Imaging
Other Name: Ultrasound Spectroscopy

Prostate Other: Imaging
Other Name: Ultrasound Spectroscopy

Rectum Other: Imaging
Other Name: Ultrasound Spectroscopy

Prostate Characterization Other: Imaging
Other Name: Ultrasound Spectroscopy




Primary Outcome Measures :
  1. Radiation Treatment Response [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Men and women who are receiving radiotherapy for head and neck cancer, or rectal cancer, and men who are receiving radiotherapy for prostate cancer
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908684


Contacts
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Contact: Gregory J Czarnota, PhD, MD (416) 480-6128 gregory.czarnota@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Gregory J Czarnota, PhD, MD    (416) 480-6128    gregory.Czarnota@sunnybrook.ca   
Principal Investigator: Gregory J Czarnota, PhD, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre

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Responsible Party: Dr. Gregory Czarnota, Radiation Oncologist and Clinician Scientist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03908684    
Other Study ID Numbers: 448-2013
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre:
Ultrasound
Spectroscopy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms