Clinical trial NCT03908684: Ultrasound Spectroscopy as Early Indicators of Radiation Treatment Response in Prostate, Rectum and Head & Neck Cancers
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Head and Neck Cancer
Rectal Cancer
Keywords: Ultrasound
Spectroscopy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility 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.

Primary outcomes:
measure: Radiation Treatment Response
timeFrame: Up to 5 years
Secondary outcomes:
measure: Radiation Treatment Long-term Clinical Outcome
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Gregory Czarnota, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.