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NCT03602911 Clinical Trial

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

Head and Neck Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03602911
Other study ID # 1137154
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 1, 2019
Est. completion date July 31, 2019

Study information
Verified date April 2019
Source West Virginia University
Contact Aimie Jones, CCRC
Phone 304- 598-6135
Email jonesai@wvumedicine.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date July 31, 2019
Est. primary completion date July 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• The isotope 68Ga, NETSPOT and 18F-FDG-PET/CT
All patients will undergo 18F-FDG-PET/CT per established protocol. Following 18F-FDG-PET/CT, the patient will undergo NETSPOT imaging

Locations
Country Name City State
United States West Virginia University Medicine Morgantown West Virginia

Sponsors (1)
Lead Sponsor Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection and Staging of Head and Neck Squamous Cell Carcinoma NETSPOT imaging will be at least equivalent to 18F FDG PET/CT in the detection and staging of HNSCC. This will be done using Standard Uptake Value (SUV) measurements. 6 months
Secondary Detection of primary site for Head and Neck Squamous Cell Carcinoma The Combination of NETSPOT imaging and 19F FDG PET/CT will have increased specificity for detecting the primary site for HNSCC of unknown primary than 18F FDG PET/CT alone. This will be done using Standard Uptake Value (SUV) measurements. 6 months
Secondary Detection of disease recurrence and metastasis following treatment The combination of NETSPOT imaging and 18F FDG PET/CT, will have increased specificity for detecting disease recurrence and metastasis following treatment than 18F FDG PET/CT alone. This will be done using Standard Uptake Value (SUV) measurements. 6 months
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