Predicting treatment Response based on Dual assessment of magnetic resonance Imaging kinetics and Circulating Tumor cells in patients with Head and Neck cancer (PREDICT-HN): matching 'liquid biopsy' and quantitative tumor modeling.

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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 100967800 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2407 (Electronic) Linking ISSN: 14712407 NLM ISO Abbreviation: BMC Cancer Subsets: MEDLINE
    • Publication Information:
      Original Publication: London : BioMed Central, [2001-
    • Subject Terms:
      Clinical Protocols* ; Magnetic Resonance Imaging*/methods; Head and Neck Neoplasms/*diagnosis ; Neoplastic Cells, Circulating/*pathology; Biomarkers ; Female ; Head and Neck Neoplasms/therapy ; Humans ; Image Processing, Computer-Assisted/methods ; Imaging, Three-Dimensional ; Liquid Biopsy ; Male ; Positron Emission Tomography Computed Tomography ; Positron-Emission Tomography ; Prognosis ; Prospective Studies ; Treatment Outcome
    • Abstract:
      Background: Magnetic resonance imaging (MRI) has improved capacity to visualize tumor and soft tissue involvement in head and neck cancers. Using advanced MRI, we can interrogate cell density using diffusion weighted imaging, a quantitative imaging that can be used during radiotherapy, when diffuse inflammatory reaction precludes PET imaging, and can assist with target delineation as well. Correlation of circulating tumor cells (CTCs) measurements with 3D quantitative tumor characterization could potentially allow selective, patient-specific response-adapted escalation or de-escalation of local therapy, and improve the therapeutic ratio, curing the greatest number of patients with the least toxicity.
      Methods: The proposed study is designed as a prospective observational study and will collect pretreatment CT, MRI and PET/CT images, weekly serial MR imaging during RT and post treatment CT, MRI and PET/CT images. In addition, blood sample will be collected for biomarker analysis at those time intervals. CTC assessments will be performed on the CellSave tube using the FDA-approved CellSearch® Circulating Tumor Cell Kit (Janssen Diagnostics), and plasma from the EDTA blood samples will be collected, labeled with a de-identifying number, and stored at - 80 °C for future analyses.
      Discussion: The primary objective of the study is to evaluate the prognostic value and correlation of weekly tumor response kinetics (gross tumor volume and MR signal changes) and circulating tumor cells of mucosal head and neck cancers during radiation therapy using MRI in predicting treatment response and clinical outcomes. This study will provide landmark information as to the utility of CTCs ('liquid biopsy) and tumor-specific functional quantitative imaging changes during treatment to guide personalization of treatment for future patients. Combining the biological information from CTCs and the structural information from MRI may provide more information than either modality alone. In addition, this study could potentially allow us to determine the optimal time to obtain MR imaging and/ or CTCs during radiotherapy to assess tumor response and provide guidance for patient selection and stratification for future dose escalation or de-escalation strategies.
      Trial Registration: Clinicaltrials.gov ( NCT03491176 ). Date of registration: 9 th April 2018. (retrospectively registered). Date of enrolment of the first participant: 30 th May 2017.
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    • Grant Information:
      R25 EB025787 United States EB NIBIB NIH HHS; RANZCR Research Grant Royal Australian and New Zealand College of Radiologists (AU); RSNA Fellow Grant Radiological Society of North America
    • Contributed Indexing:
      Keywords: Biomarker; Circulating tumor cells; Head and neck cancer; Magnetic resonance imaging
    • Molecular Sequence:
      ClinicalTrials.gov NCT03491176
    • Accession Number:
      0 (Biomarkers)
    • Publication Date:
      Date Created: 20180921 Date Completed: 20181211 Latest Revision: 20220716
    • Publication Date:
      20240105
    • Accession Number:
      PMC6148797
    • Accession Number:
      10.1186/s12885-018-4808-5
    • Accession Number:
      30231854