Usefulness of Integrated PET/MRI in Oropharyngeal Squamous Cell Carcinoma Evaluation

NCT05299957 | Completed

• 1 other identifier: 201407314A3
• Study Type: observational
• Target: 233
• 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, while endoscopy with biopsy serves as the main diagnostic tools. 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, intravoxel incoherent motion (IVIM) model and Kurtosis (biexponential or non-Gaussian fitting), and dynamic contrast-enhanced perfusion weighted MRI (DCE-PWI) become feasible. Therefore, MRI can evaluate distant site status of HNC in the single examination session and provide biologic information of tumors. 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. In this 3-year prospective study, the investigators will take the advantages of integrated PET/MRI scanner with DWI (including monoexponential, kurtosis and IVIM modes) and 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 determine whole-body staging/restaging accurately, to predict treatment response and prognosis, and 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 CT 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 of oropharyngeal SCC subjected to chemoradiation, which are important in timely modification of treatment regimen.

Conditions

Oropharyngeal Cancer

Keywords

Oropharyngeal cancer; integrated PET/MR

Outcome Measures

Primary Outcomes (1)

• Primary tumor staging of oropharyngeal cancer by PET/MR

  correlation of size of primary tumor(cm), size of metastatic nodes (cm), and number of distant metastasis with PET, MRI and PET/MR

  2 years

Secondary Outcomes (1)

• Survival of oropharyngeal cancer by FDG uptake of PETMT

  4 years

Study Arms (1)

oropharyngeal squamous cell carcinoma

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, or intracranial aneurysmal ferromagnetic clips), and serum glucose level \>200 mg/dl. Each enrolled patients will undergo detail clinical examination, including human papillomavirus test.

Diagnostic Test: PETMRI

Interventions

PETMRI DIAGNOSTIC_TEST

PET/MRI data will be acquired on the integrated PET/MRI scanner. After fast-view T1-weighted MR localizer sequence for scout imaging and Dixon VIBE sequence for attenuation correction, a whole-body PET scan will be performed to cover from the head to the proximal thigh, with an acquisition time of 4 min per bed position. Simultaneously, whole body MR image acquisition will be performed with the axial HASTE sequence and coronal STIR sequence as well as the sagittal T1-weighted Turbo spine echo and STIR sequence. Afterwards, regional PET and MRI images will be simultaneously performed. DWI will be performed using a single shot spin-echo echo-planar technique. A total of 10 b values will be used for the reconstruction of IVIM and kurtosis imaging. DCE-PWI will be acquired by using a 3D T1-weighted spoiled gradient-echo sequence. Thereafter, dedicated regional MRI will be obtained. Finally, whole body axial VIBE with fat saturation will be performed.

oropharyngeal squamous cell carcinoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in a tertiary referral center

You may qualify if:

• histologically proven oropharyngeal SCC subjected to chemoradiation

You may not qualify if:

• previous head or neck malignant tumor, a second malignant tumor, distant metastasis, contraindications to MRI (renal insufficiency, cochlear implant, cardiac pacemaker

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital

Guishan, Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• WU SHU-CHIEN

  Department of Medic Imaging and Intervention, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 29, 2022
• Study Start: August 1, 2015
• Primary Completion: October 31, 2018
• Study Completion: December 31, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

TW (1)