A Comparison of NETSPOT Imaging Versus F-FDG-PET in Head and Neck Cancer Patients

West Virginia University

Status and phase: Completed; Phase 2

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Drug: The isotope 68Ga, NETSPOT and 18F-FDG-PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03602911

1804059675

Details and patient eligibility

About

This is a proof-of-concept trial to compare 18F-FDG-PET/CT with NETSPOT (68Ga-DOTA-TATE), a commercially available radiotracer packet that utilizes 68Ga to image SSTR-specific tissue.

Full description

Patients meeting inclusion criteria will be consented at the time of scheduling. All patients will undergo 18F-FDG-PET/CT per established protocol. Following 18F-FDG-PET/CT, the patient will undergo NETSPOT imaging with the AAA-provided dose. These scans will be performed no less than 8 hours, no more than 7 days apart. For patients undergoing same-day imaging, NETSPOT imaging will be performed prior to 18F-FDG-PET/CT. Following imaging, both 18F-FDG-PET/CT and NETSPOT imaging will be compared by trained neuroradiologists for SUV values and concordance with known sites of disease. Biopsies will be performed as is standard to verify all sites of primary or metastatic disease. Patients with oropharyngeal tumors will have HPV testing performed via the standard of care surrogate marker p16. Patients with p16-positive tumors will be recorded and analyzed separately for the above measures. Patients will be followed for a total of 1 year after the study and outcomes of overall survival, disease-free survival, presence and site of recurrence and development of metastatic disease will be recorded. All gathered data will be compared between reported 18F-FDG-PET/CT and NETSPOT imaging for true positive, true negative, positive predictive value and negative predictive value of patient groups.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with suspected or diagnosed HNSCC undergoing planned 18F FDG PET/CT at the time of primary diagnosis or after completion of treatment.

Exclusion criteria

Inability to undergo 18F-FDG-PET/CT imaging due to medical comorbidities

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Proof of Concept

Other group

Description:

The isotope 68Ga, available as NETSPOT and 18F-FDG-PET/CT per established protocol will both be administered

Treatment:

Drug: The isotope 68Ga, NETSPOT and 18F-FDG-PET/CT