West Virginia University Medicine
Morgantown, West Virginia, 26501, United States
NCT Number: NCT03602911
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Morgantown, West Virginia, 26501, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
All patients will undergo 18F-FDG-PET/CT per established protocol. Following 18F-FDG-PET/CT, the patient will undergo NETSPOT imaging
Time frame: From Baseline up to day 7 post imaging
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. SUV max of > 2.5 for 18F-FDG-PET and > 1.5 for 68GA DOTATATE-PET/CT were used as thresholds of concern.
Using the PET scan, investigators calculated the standard uptake value (SUV), to compare the amount of an agent injected into the patient and the amount taken up by the tumor.
Time frame: From Baseline up to day 7 post imaging
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. SUV max of > 2.5 for 18F-FDG-PET and > 1.5 for 68GA DOTATATE-PET/CT were used as thresholds of concern.
Using the PET scan, radiologists can calculate the standard uptake value (SUV), to compare the amount of an agent injected into the patient and the amount taken up by the tumor.
West Virginia University
Other
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