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

The Washington University

Status: Terminated

Conditions: Squamous Cell Carcinoma

Treatments: Device: FDG PET/CT; Device: Diffusion-weighted imaging magnetic resonance imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04685798

201912072

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

DWI MRI + Standard of care FDG PET/CT

Experimental group

Description:

-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.

Treatment:

Device: Diffusion-weighted imaging magnetic resonance imaging

Device: FDG PET/CT