Studies on batch formulation of a freeze dried kit for the preparation of Tc-HYNIC-TATE for imaging neuroendocrine tumors.

AIM

To formulate freeze dried cold kits for preparation of Tc-HYNIC-TATE suitable for use at hospital radiopharmacy and establish clinical utility of Tc-HYNIC-TATE prepared using kits for detection of neuroendocrine tumors (NETs).

METHODS

Standardization of reagent concentrations for formulation of freeze dried kits of HYNIC-TATE was carried out. Consistency in formulation was tested by six batch preparation. Quality control tests were carried out to establish compliance of specifications of purity and safety criteria for both kits and Tc-HYNIC-TATE formulated using kits. Clinical utility of Tc-HYNIC-TATE prepared using kits was demonstrated in patients with histopathologically confirmed well-differentiated NETs.

RESULTS

Pharmaceutical grade HYNIC-TATE kits compliant with all the quality control criteria were formulated and successfully radiolabeled with Tc. Radiopharmaceutical was successfully utilized for detection of NETs in patients and comparison with uptake of Tc-HYNIC-TOC and Lu-DOTA-TATE was made.

CONCLUSION

The formulated kits are robust and provide consistently high radiolabeling yields (> 95%) with Tc in short time periods requiring no additional purification. Initial clinical trials demonstrate the utility of Tc-HYNIC-TATE using formulated kits.