- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gregory J Czarnota, PhD, MD
- Phone Number: (416) 480-6128
- Email: gregory.czarnota@sunnybrook.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- SunnyBrook Health Sciences Centre
-
Contact:
- Gregory J Czarnota, PhD, MD
- Phone Number: (416) 480-6128
- Email: gregory.czarnota@sunnybrook.ca
-
Principal Investigator:
- Gregory J Czarnota, Phd, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
|
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.
|
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.
Other Names:
|
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation Treatment Response
Time Frame: Up to 5 years
|
Evaluate tumour response to radiotherapy as measured radiologically within the treated therapeutic region.
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation Treatment Long-term Clinical Outcome
Time Frame: Up to 5 years
|
Evaluating tumour response to radiotherapy as measured radiologically within the treated therapeutic region and assessing long-term clinical outcomes.
|
Up to 5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gregory Czarnota, PhD, MD, SunnyBrook Health Sciences Centre
Publications and helpful links
General Publications
- Fatima K, Dasgupta A, DiCenzo D, Kolios C, Quiaoit K, Saifuddin M, Sandhu M, Bhardwaj D, Karam I, Poon I, Husain Z, Sannachi L, Czarnota GJ. Ultrasound delta-radiomics during radiotherapy to predict recurrence in patients with head and neck squamous cell carcinoma. Clin Transl Radiat Oncol. 2021 Mar 12;28:62-70. doi: 10.1016/j.ctro.2021.03.002. eCollection 2021 May.
- Osapoetra LO, Dasgupta A, DiCenzo D, Fatima K, Quiaoit K, Saifuddin M, Karam I, Poon I, Husain Z, Tran WT, Sannachi L, Czarnota GJ. Assessment of clinical radiosensitivity in patients with head-neck squamous cell carcinoma from pre-treatment quantitative ultrasound radiomics. Sci Rep. 2021 Mar 17;11(1):6117. doi: 10.1038/s41598-021-85221-6.
- Dasgupta A, Fatima K, DiCenzo D, Bhardwaj D, Quiaoit K, Saifuddin M, Karam I, Poon I, Husain Z, Tran WT, Sannachi L, Czarnota GJ. Quantitative ultrasound radiomics in predicting recurrence for patients with node-positive head-neck squamous cell carcinoma treated with radical radiotherapy. Cancer Med. 2021 Apr;10(8):2579-2589. doi: 10.1002/cam4.3634. Epub 2020 Dec 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 448-2013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
-
IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
-
University of California, San FranciscoCompleted
-
Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
Radboud University Medical CenterUnknown
-
Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
Clinical Trials on Ultrasound Imaging
-
The Hospital for Sick ChildrenCompleted
-
Mayo ClinicNational Cancer Institute (NCI); National Institute for Biomedical Imaging...RecruitingBreast CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Withdrawn
-
Mayo ClinicTerminated
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Baylor College of MedicineUniversity of Texas Southwestern Medical Center; Cancer Prevention Research...RecruitingHuman Papillomavirus InfectionUnited States
-
National Cancer Institute (NCI)Active, not recruitingOvarian Carcinoma | Ovarian Germ Cell TumorUnited States
-
Ohio State University Comprehensive Cancer CenterWithdrawn
-
Rijnstate HospitalRadboud University Medical CenterRecruitingCarotid Artery StenosisNetherlands
-
Thomas Jefferson UniversityRecruitingBreast CarcinomaUnited States