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

NCT03908684 | Recruiting

• 1 other identifier: 448-2013
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer; Head and Neck Cancer; Rectal Cancer

Keywords

Ultrasound; Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Radiation Treatment Response

  Evaluate tumour response to radiotherapy as measured radiologically within the treated therapeutic region.

  Up to 5 years

Secondary Outcomes (1)

• Radiation Treatment Long-term Clinical Outcome

  Up to 5 years

Study Arms (3)

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.

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.

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.

Device: Ultrasound Imaging

Interventions

Ultrasound Imaging DEVICE

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.

Also known as: Ultrasound Spectroscopy

Head and Neck; Prostate; Rectum

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Related Publications (4)

• 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.

  PMID: 38391311 DERIVED

• 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.

  PMID: 33778174 DERIVED

• 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.

  PMID: 33731738 DERIVED

• 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.

  PMID: 33314716 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Head and Neck Neoplasms; Rectal Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gregory Czarnota, PhD, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory J Czarnota, PhD, MD

CONTACT

(416) 480-6128; gregory.czarnota@sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist and Clinician Scientist

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 9, 2019
• Study Start: December 17, 2014
• Primary Completion: December 17, 2025
• Study Completion (Estimated): December 17, 2029
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

CA (1)