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Radiomic Analysis for Predicting Treatment Response and Clinical Outcomes in Malignancies

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05170087
Collaborator
(none)
1,200
Enrollment
1
Location
60
Anticipated Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, the investigators aim to undertake a retrospective analysis of CT and MRI scans for patients undergoing radiation treatment to develop radiomic signatures to predict treatment response and clinical outcomes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Imaging in oncology has widespread application with modalities like ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) having a well-established role particularly in diagnosis, staging, assessment of treatment response, and surveillance. With the applications of radiomics in oncology, the potential of imaging as a non-invasive biomarker in treatment response, as well as genotypic characterization, has been recognized. Radiomics has the potential to tailor way towards precision oncology with the development of biomarkers that can guide personalized treatments. In this study, the investigators aim at developing CT and MRI radiomic signatures as potential biomarkers to predict treatment response and clinical outcomes for patients treated with radiation having breast, brain, head and neck, and gynecological malignancies.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Radiomic Analysis of CT and MRI Scans for Predicting Treatment Response and Clinical Outcomes in Patients With Breast, Brain, Head-neck and Gynecological Malignancies
    Actual Study Start Date :
    Mar 2, 2020
    Anticipated Primary Completion Date :
    Mar 1, 2025
    Anticipated Study Completion Date :
    Mar 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Breast malignancies

    Those diagnosed with breast malignancies
    Head and Neck malignancies

    Those diagnosed with head and neck malignancies
    Brain malignancies

    Those diagnosed with brain malignancies
    Gynecological malignancies

    Those diagnosed with gynecological malignancies

    Outcome Measures

    Primary Outcome Measures

    1. Development of imaging biomarkers in predicting treatment response for breast, brain, head-neck, and gynecological malignancies [1 year]

      Development of imaging biomarkers in predicting treatment response

    2. Development of imaging biomarkers in predicting clinical outcomes (survival/toxicity) for breast, brain, head-neck, and gynecological malignancies [1 year]

      Development of imaging biomarkers in predicting clinical outcomes (survival/toxicity)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Breast, head and neck, brain, and gynecological malignancies

    • Treated with radiation at Odette Cancer Centre between 2010 and 2019

    Exclusion Criteria:
    • N/A

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

    Sponsors and Collaborators

    • Sunnybrook Health Sciences Centre

    Investigators

    • Principal Investigator: Gregory Czarnota, Ph.D. M.D., Sunnybrook Health Sciences Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Gregory Czarnota, Radiation Oncologist and Clinical Scientist, Sunnybrook Health Sciences Centre
    ClinicalTrials.gov Identifier:
    NCT05170087
    Other Study ID Numbers:
    • 034-2020
    First Posted:
    Dec 27, 2021
    Last Update Posted:
    Dec 27, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Neoplasms

    Study Results

    No Results Posted as of Dec 27, 2021