Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-02

Study Completion Date

2023-09-26

Brief Summary

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The investigators propose a longitudinal study evaluating post-treatment changes in patients with squamous cell carcinoma (SCC) of the neck using an innovative optimized diffusion-weighted imaging (DWI) pulse sequence to identify more accurately recurrent tumors as well as early non-responders to therapy.

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Detailed Description

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Conditions

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Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

All anonymized MRI studies will be blindly evaluated by at least two experienced neuroradiologists

Study Groups

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DWI MRI + Standard of care FDG PET/CT

-The patients will undergo an optimized research neck DWI MRI, up to 3 weeks post-treatment and then a standard-of-care 3-month post-treatment FDG PET/CT examination.

Group Type EXPERIMENTAL

Diffusion-weighted imaging magnetic resonance imaging

Intervention Type DEVICE

The research MRI study of the head and neck will be performed on a Siemens 3T MRI Scanner system

FDG PET/CT

Intervention Type DEVICE

Standard of care

Interventions

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Diffusion-weighted imaging magnetic resonance imaging

The research MRI study of the head and neck will be performed on a Siemens 3T MRI Scanner system

Intervention Type DEVICE

FDG PET/CT

Standard of care

Intervention Type DEVICE

Other Intervention Names

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DWI MRI

Eligibility Criteria

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Inclusion Criteria

* Histologically-proven newly diagnosis or recurrence as indicated by tissue diagnosis of T3 or T4 squamous cell carcinoma of the head and neck
* Must have had or be scheduled for standard-of-care surgical resection, radiation, and/or chemo-radiation of the diagnosed squamous cell carcinoma of the head and neck
* At least 18 years of age
* Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria

* Contraindications to MRI, including:

* MRI-incompatible implantable devices
* severe claustrophobia; and
* Pregnant and/or breastfeeding, with women of childbearing potential having a negative urine or serum pregnancy test

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No