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PET/MRI in Oropharyngeal Squamous Cell Carcinoma Evaluation

NCT03163797 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2017-07-02

No results posted yet for this study

Summary

Head and neck cancer (HNC) continues to be a significant health care problem in Taiwan and oropharyngeal squamous cell carcinoma (SCC) is the common subtype. With the concern of organ preservation in recent years, concurrent chemoradiation is the major treatment modality for oropharyngeal SCC. Endoscopy with biopsy serve as the main diagnostic tools in patients with oropharyngeal SCC. While computed tomography (CT) and magnetic resonance imaging (MRI) are commonly used to evaluate the tumor extent of HNC, MRI is more preferred in the oropharyngeal area by virtue of its high contrast resolution. With the advance of MRI technology, whole body MRI is now possible, and functional techniques become more feasible in the head and neck region, including diffusion-weighted imaging (DWI) which comprises of monoexponential DWI, IVIM (intravoxel incoherent motion) model and Kurtosis (biexponential or non-Gaussian fitting), and perfusion-weighted imaging (PWI) become feasible. Therefore, MRI can evaluate distant site status of HNC in the single examination session and provide biologic information of tumors, such as cellularity, angiogenesis and permeability, and so forth. Positron emission tomography/CT (PET/CT) is another common imaging modality to evaluate HNC, because of its ability to provide whole-body anatomic and metabolic information.

Integrated PET/MRI is a novel imaging technology that combines PET and MRI in one single scanner. It can acquire both PET and MRI information simultaneously. Initial data convey that PET/MRI performed favorably in diagnostic evaluation of HNC. However, the predictive value of PET/MRI in treatment outcome of HNC has not been reported. A prospective study of integrated PET/MRI in a large cohort of patients with specific tumor origin and uniform treatment protocol is needed to fully validate the clinical usefulness of this novel integrated system.

In this 3-year prospective study, the investigators will take the advantages of integrated PET/MRI scanner with diffusion-weighted MRI (DWI) and dynamic contrast-enhanced perfusion weighted MRI (DCE-PWI) to evaluate our 160 patients with oropharyngeal SCC subjected to chemoradiation. Non-contrast chest CT will also be performed on the same day. The investigators aim to (1) determine whole-body staging/restaging accurately, (2) predict treatment response and prognosis, and (3) to determine necessity of noncontrast chest CT. The investigators expect that this project will offer the validation of usefulness of integrated PET/MRI in tumor staging/restaging of oropharyngeal SCC and resultant clinical impact. The role of noncontrast chest in the workup with our PET/MRI protocol can be defined. It will also provide evidence about how and to what extent the various simultaneously acquired MRI and PET functional parameters can help prediction of treatment response and prognosis, which are important in timely modification of treatment regimen.

Conditions

Interventions

DIAGNOSTIC_TEST

PET/MRI for evaluation

Before pretreatment, each enrolled patients will undergo PET/MRI and detail clinical examination, including human papillomavirus test. They will also undergo low dose chest CT on the same day before PET/MRI. In the posttreatment period, baseline whole body MRI will be obtained 3 months after chemoradiation. Thereafter, the patients will then be followed up also with alternative extend-field CT and whole body MRI by every 6 months. If tumor recurrence is confirmed or highly suspected, PET/MRI will also be performed for tumor re-staging.

Sponsors & Collaborators

  • Ministry of Science and Technology, Taiwan

    collaborator OTHER_GOV

  • Chang Gung Memorial Hospital

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163797 on ClinicalTrials.gov