68Ga-DOTA-MGS5 PET/CT in Patients With Advanced Neuroendocrine Tumours

Summary

68Ga-labelled \[DOTA0,DGlu1,desGlu2-6,(N-Me)Nle11,1-Nal13\]minigastrin (68Ga-DOTA-MGS5) is a novel radiopharmaceutical for intravenous administration for evaluation of the cholecystokinin receptor (CCK2R) status in patients with CCK2R-related malignancies. CCK2R is expressed at high incidence in medullary thyroid carcinomas (92%) and frequently expressed also in gastroenteropancreatic neuroendocrine tumours (GEP-NET, 22%). In this phase I/IIa study the safety of administration and the biodistribution of 68Ga-DOTA-MGS5 will be evaluated in patients with advanced MTC as well as gastroenteropancreatic and bronchopulmonary NET. In addition, the visualization of tumour lesions as well as the absorbed organ and tumour radiation dose will be evaluated. The new positron emission tomography (PET) imaging modality has the potential to improve the diagnostic accuracy in patients with advanced MTC as well as gastroenteropancreatic and bronchopulmonary NET. After successful application in diagnostic imaging, CCK2R targeting with therapeutic radionuclides bears high potential also to improve the therapeutic management of patients with advanced disease.

Timeline

Start

2021-01-20

Primary completion

2023-06-30

Completion

2023-06-30

Publications

• Uprimny C, von Guggenberg E, Sviridenko A, Bayerschmidt S, Rossetti LM, Roustaei H, Warwitz B, Ulmer H, Hutter A, di Santo G, Virgolini IJ. Diagnostic Performance of the 68Ga-Labeled Minigastrin Analog DOTA-MGS5 in Patients with Advanced Medullary Thyroid Cancer and Other Neuroendocrine Tumors. J Nucl Med. 2025 Oct 1;66(10):1581-1588. doi: 10.2967/jnumed.125.269863.
• von Guggenberg E, di Santo G, Uprimny C, Bayerschmidt S, Warwitz B, Hormann AA, Zavvar TS, Rangger C, Decristoforo C, Sviridenko A, Nilica B, Santo G, Virgolini IJ. Safety, Biodistribution, and Radiation Dosimetry of the 68Ga-Labeled Minigastrin Analog DOTA-MGS5 in Patients with Advanced Medullary Thyroid Cancer and Other Neuroendocrine Tumors. J Nucl Med. 2025 Feb 3;66(2):257-263. doi: 10.2967/jnumed.124.268877.

Drugs

Indications