PET/MRI in Oropharyngeal Squamous Cell Carcinoma Evaluation

NCT03163797 | Unknown

• 1 other identifier: MOST 104-2314-B-182A-091 -MY3
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Head and Neck Cancer

Keywords

Oropharyngeal cancer; integrated PET/MR; diffusion-weighted imaging; perfusion-weighted imaging

Outcome Measures

Primary Outcomes (3)

• Whole-body staging/restaging using integrated PET/MRI

  The feasibility and accuracy of integrated PET/MRI in detection of locoregional tumor extent, regional nodal metastases and distant metastases for staging and tailored treatment of oropharyngeal SCC of the 160 participants.

  3 years

• Treatment response and prognosis

  We aim to obtain MRI and PET functional results and evaluate for the predictive values of integrated PET/MRI system in the single imaging session of the patient cohort of oropharyngeal SCC uniformly treated with chemoradiation, and also to evaluate the clinical usefulness of the various functional parameters of integrated PET/ MRI in avoiding unnecessary or fruitless treatments.

  3 years

• Necessity of noncontrast chest CT

  To prospectively validate the performance of our integrated PET/MRI protocol sequences for lung lesions by comparing with a noncontrast enhanced CT for detection of subtle lung metastases for the patient cohort.

  3 years

Study Arms (1)

Oropharyngeal cancer

A total of 160 patients with histologically proven oropharyngeal SCC subjected to chemoradiation will be enrolled. Exclusion criteria include previous head or neck malignant tumor, a second malignant tumor, distant metastasis, contraindications to MRI (renal insufficiency, cochlear implant, cardiac pacemaker placement or intracranial aneurysmal ferromagnetic clips), and serum glucose level \>200 mg/dl. Before pretreatment, each enrolled patients will undergo PET/MRI and detail clinical examination, including human papillomavirus test.

Diagnostic Test: PET/MRI for evaluation

Interventions

PET/MRI for evaluation DIAGNOSTIC_TEST

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.

Oropharyngeal cancer

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 160 patients with histologically proven oropharyngeal SCC subjected to chemoradiation will be enrolled.

You may qualify if:

• histologically proven oropharyngeal SCC subjected to chemoradiation

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Guishan, Taoyuan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: May 23, 2017
• Study Start: August 1, 2015
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: July 2, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)