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
Sweet Ping Ng,
Houda Bahig,
Jihong Wang,
Carlos E. Cardenas,
Anthony Lucci,
Carolyn S. Hall,
Salyna Meas,
Vanessa N. Sarli,
Ying Yuan,
Diana L. Urbauer,
Yao Ding,
Shane Ikner,
Vi Dinh,
Baher A. Elgohari,
Jason M. Johnson,
Heath D. Skinner,
G. Brandon Gunn,
Adam S. Garden,
Jack Phan,
David I. Rosenthal,
William H. Morrison,
Steven J. Frank,
Katherine A. Hutcheson,
Abdallah S. R. Mohamed,
Stephen Y. Lai,
Renata Ferrarotto,
Michael P. MacManus,
Clifton D. Fuller
Affiliations
Sweet Ping Ng
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
Houda Bahig
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
Jihong Wang
Department of Radiation Physics, University of Texas MD Anderson Cancer Center
Carlos E. Cardenas
Department of Radiation Physics, University of Texas MD Anderson Cancer Center
Anthony Lucci
Department of Breast Surgical Oncology, University of Texas MD Anderson Cancer Center
Carolyn S. Hall
Department of Breast Surgical Oncology, University of Texas MD Anderson Cancer Center
Salyna Meas
Department of Breast Surgical Oncology, University of Texas MD Anderson Cancer Center
Vanessa N. Sarli
Department of Breast Surgical Oncology, University of Texas MD Anderson Cancer Center
Ying Yuan
Department of Biostatistics, University of Texas MD Anderson Cancer Center
Diana L. Urbauer
Department of Biostatistics, University of Texas MD Anderson Cancer Center
Yao Ding
Department of Radiation Physics, University of Texas MD Anderson Cancer Center
Shane Ikner
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
Vi Dinh
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
Baher A. Elgohari
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
Jason M. Johnson
Department of Diagnostic Radiology, University of Texas MD Anderson Cancer Center
Heath D. Skinner
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
G. Brandon Gunn
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
Adam S. Garden
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
Jack Phan
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
David I. Rosenthal
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
William H. Morrison
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
Steven J. Frank
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
Katherine A. Hutcheson
Department of Head and Neck Surgery, University of Texas MD Anderson Cancer Center
Abdallah S. R. Mohamed
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
Stephen Y. Lai
Department of Head and Neck Surgery, University of Texas MD Anderson Cancer Center
Renata Ferrarotto
Department of Thoracic Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center
Michael P. MacManus
Department of Radiation Oncology, Peter MacCallum Cancer Centre
Clifton D. Fuller
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
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: 9th April 2018. (retrospectively registered). Date of enrolment of the first participant: 30th May 2017.
