177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

October 28, 2025

Primary Completion Date

July 1, 2032

Study Completion Date

August 1, 2032

Conditions
Thyroid Cancer
Interventions
DIAGNOSTIC_TEST

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.

OTHER

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.

DRUG

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.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

NCT06991738 - 177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer | Biotech Hunter | Biotech Hunter