50 patients with pathology diagnosed melanoma will be enrolled for the clinical study. If
agree to take part in this study, the patient will be performed with 18F-P3BZA PET/CT scan
and 18F-FDG PET/CT scan in the other day before and after surgery. Next, all of the resected
tissues from the patients will be checked with pathology.
6 of 50 patients are performed for whole-body PET scans at 0, 15, 30, 45, 60, and 120 minutes
and a CT scan at 60 minutes after tracer injection (mean dose, 5.0 ± 0.5 mCi in 2.0 ± 0.5ml)
will be performed. During the imaging period, 1 mL blood samples will be obtained for
time-activity curve calculations at 1, 5, 10, 30,60, 90, 120, and 180 minutes after
injection. The estimated radiation doses will be calculated by using OLINDA/EXM software.
The images produced by these scans will be compared to see the diagnosis value of 18F-P3BZA.
Women who decide to take part in this study will be asked if they think they might be
pregnant at the start of the study. All of them must have a negative blood pregnancy test
(Human chorionic gonadotropin, HCG).
PET-CT Scan Procedure:
Before the PET-CT scan is performed, patient will be asked to remove any metallic objects
when she/he arrive at the PET-CT Center. After a property rest, he/she will be injected with
about 5mCi 18F-P3BZA. The first scan will take at 60 minutes after injection and a delay scan
will take at 120 minutes after injection. Each PET/CT scan will take about 20 minutes.
After 18F-P3BZA scan, the patient will be asked to avoid stressful exercise. Starting about
12 hours before 18F-FDG scan, he/she will be asked to limit the amount of carbohydrates until
the scans are done.
Patients' primary care physician will follow-up them for next 24 hours. After then, they may
order additional imaging or surgical results after this study for follow-up purposes. The
study doctor will review these results to compare them with the PET-CT images. The study
doctors will also review the results of any biopsies you may have had as a result of PET-CT
This is an investigational study. PET-CT and CT scans are FDA approved and commercially