Prostate CancerNCT03908684
Ultrasound Spectroscopy as Early Indicators of Radiation Treatment Response in Prostate, Rectum and Head & Neck Cancers
An observational study of Prostate Cancer and Head and Neck Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prostate Cancer, Head and Neck Cancer, Rectal Cancer
- What is being tested?
- Ultrasound Imaging
- Type of treatment
- Medical device
- How many people
- 320 participants
- Where
- 1 siteCanada
- Study dates
- 17 Dec 2014to 17 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- (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:
- 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
Who cannot join
- (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:
- previous radiotherapy to an involved area (ii) active collagen vascular disease (iii) genetic diseases associated with hyper-radiosensitivity
Show all 11Show fewer
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Gregory J Czarnota, PhD, MD, (416) 480-6128, gregory.Czarnota@sunnybrook.ca
Gregory J Czarnota, PhD, MD
About this study
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
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
Read the detailed 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.
- Conditions
- Prostate Cancer, Head and Neck Cancer, Rectal Cancer
- Being tested
- Ultrasound Imaging
- Keywords
- Ultrasound, Spectroscopy
- Medical subject headings
- Prostatic Neoplasms, Head and Neck Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ImagingDevice
Also called Ultrasound Spectroscopy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ultrasound Imaging | |
| 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. Receives: Device: Ultrasound Imaging | |
| 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. Receives: Device: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Treatment Response
Evaluate tumour response to radiotherapy as measured radiologically within the treated therapeutic region.
Measured: Up to 5 years
Secondary outcomes (1)
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start17 Dec 2014
- Primary completion17 Dec 2025 (estimated)
- Study completion17 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre
- Investigators
- Gregory Czarnota, PhD, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908684
- Sponsor's protocol ID
- 448-2013
- Status last verified
- Dec 2023
- First submitted
- 8 Apr 2019
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Osapoetra LO, Dasgupta A, DiCenzo D, Fatima K, Quiaoit K, Saifuddin M, Karam I, Poon I, Husain Z, Tran WT, Sannachi L, Czarnota GJ. Quantitative US Delta Radiomics to Predict Radiation Response in Individuals with Head and Neck Squamous Cell Carcinoma. Radiol Imaging Cancer. 2024 Mar;6(2):e230029. doi: 10.1148/rycan.230029.
PubMed 38391311Fatima 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.
PubMed 33778174Osapoetra 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.
PubMed 33731738Dasgupta 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.
PubMed 33314716
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03908684
- Acronym / sponsor ID
- 448-2013
- Conditions
- Prostate Cancer, Head and Neck Cancer, Rectal Cancer
- Keywords
- Ultrasound, Spectroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 17 Dec 2014 (actual)
- Primary completion
- 17 Dec 2025 (estimated)
- Study completion
- 17 Dec 2029 (estimated)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Head and Neck | – | Device: Ultrasound ImagingThe 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 | – | Device: Ultrasound ImagingThe 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 | – | Device: Ultrasound ImagingThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- (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:
Key exclusion criteria (11 listed)
- (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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound ImagingAlso: Ultrasound SpectroscopyUltrasound 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. | Device | Head and Neck, Prostate, Rectum |
Primary outcome
Radiation Treatment Response
Time frame: Up to 5 years
Evaluate tumour response to radiotherapy as measured radiologically within the treated therapeutic region.
1 secondary outcome
Radiation Treatment Long-term Clinical Outcome
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Derived from this study: PubMed 38391311Osapoetra LO, Dasgupta A, DiCenzo D, Fatima K, Quiaoit K, Saifuddin M, Karam I, Poon I, Husain Z, Tran WT, Sannachi L, Czarnota GJ. Quantitative US Delta Radiomics to Predict Radiation Response in Individuals with Head and Neck Squamous Cell Carcinoma. Radiol Imaging Cancer. 2024 Mar;6(2):e230029. doi: 10.1148/rycan.230029.
- Derived from this study: PubMed 33778174Fatima 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.
- Derived from this study: PubMed 33731738Osapoetra 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.
- Derived from this study: PubMed 33314716Dasgupta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory Czarnota, PhD, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Head and Neck Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory J Czarnota, PhD, MD ((416) 480-6128, gregory.czarnota@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Treatment Response (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03908684, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.