18
Participants
Start Date
October 28, 2025
Primary Completion Date
July 1, 2032
Study Completion Date
August 1, 2032
68Ga-DOTA-TATE PET Scan
68Ga-DOTATATE is administered via intravenous injection of 5 1 mCi in a volume of 3 - 5 ml containing up to 50 micrograms \[68Ga\] DOTATATE.
Amino acid infusions
Appropriate amino acid solutions infused for this purpose should have a total lysine and arginine content between 18g and 25g and have an osmolality of \<= 1050 mOsmol. Concomitant administration of an amino acid infusion with the study drug 177Lu-DOTA-EB-TATE is for renal protection.
177Lu-DOTA-EB-TATE
Each single-dose vial contains sodium acetate (24.6 mg/mL), gentisic acid (3.7 mg/mL), L-ascorbate (0.445 mg/mL), DTPA (0.051 mg/mL). 177Lu-DOTA-EB-TATE, is a long-acting radiopharmaceutical for PRRT. It consists of a somatostatin analog peptide (TATE) conjugated with a truncated Evans blue (EB) molecule and the metal chelator 1,4,7,10-tetraazacyclodecane-1,4,7,10-tetraacetic acid (DOTA) with the radioisotope 177Lu stably complexed.
National Institutes of Health Clinical Center, Bethesda
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH