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. 2018 Sep 19;18(1):903.
doi: 10.1186/s12885-018-4808-5.

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  1 , Houda Bahig  2 , Jihong Wang  3 , Carlos E Cardenas  3 , Anthony Lucci  4 , Carolyn S Hall  4 , Salyna Meas  4 , Vanessa N Sarli  4 , Ying Yuan  5 , Diana L Urbauer  5 , Yao Ding  3 , Shane Ikner  2 , Vi Dinh  2 , Baher A Elgohari  2 , Jason M Johnson  6 , Heath D Skinner  2 , G Brandon Gunn  2 , Adam S Garden  2 , Jack Phan  2 , David I Rosenthal  2 , William H Morrison  2 , Steven J Frank  2 , Katherine A Hutcheson  7 , Abdallah S R Mohamed  2 , Stephen Y Lai  7 , Renata Ferrarotto  8 , Michael P MacManus  9 , Clifton D Fuller  2
Affiliations

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 et al. BMC Cancer. .

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.

Keywords: Biomarker; Circulating tumor cells; Head and neck cancer; Magnetic resonance imaging.

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Conflict of interest statement

Ethics approval and consent to participate

This study is in accordance with the Declaration of Helsinki and has been approved by the Institutional Review Board at the University of Texas MD Anderson Cancer Center. The study is registered on clinicaltrials.gov (NCT03491176).

Patients within the institution, who are scheduled for definitive radiotherapy, will be identified by either an attending physician or research fellow in the Department of Radiation Oncology. During clinic appointments, potential subjects will be informed of their eligibility and asked if they would be interested in research participation. In the privacy of the exam room, the treating physician or research fellow will discuss all aspects of the study with potential subjects and answer any questions. Interested subjects then have a consent interview with the research nurse or research data coordinator in the exam room or other private area (i.e. patient education/consultation room). Subjects will be given a copy of the Informed Consent and will be further instructed about the study and the elements of the consent document. The subject will be given as much time as needed to review and discuss the study and consent and the research nurse or research data coordinator will answer any remaining questions. The treating physician is also available to address any questions or concerns the subject may have. Subjects who agree to participate will sign the protocol-specific informed consent. Non-English speaking patients will be consented using an MD Anderson Translator and a verbal translation preparative sheet using MD Anderson policies for Informed Consent translation in that patient’s primary language. Once two patients have been consented in a given language, the research nurse or research data coordinator will request institutional translation of the entire consent into that language. Patients may withdraw from the study at any time without any penalty. If a patient withdraws, any blood or tissue not already used will not be used for further studies.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1
Fig. 1
Research protocol workflow. * If receiving induction chemotherapy, first sample of blood collected pre-chemotherapy
Fig. 2
Fig. 2
Research schema
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