TheranosticTrials.org

Clinical Trial · NCT06155994

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

Overview

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.

Sponsor

Medical University of Warsaw

Phase

Phase 1/2

Contacts

Irene Virgolini, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06155994

Drug / Compound

MGS5

Isotope(s):
Target(s):
  • Cholecystokinin-2 (CCK2R)
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Histopathologically diagnosed locally advanced or metastatic MTC with calcitonin level \>100 pg/mL after total thyroidectomy or other histologically diagnosed advanced gastroenteropancreatic and bronchopulmonary NET with known metastases
  • Karnofsky performance status \>70
  • Patients with an advanced stage of the disease as documented by local or distant metastasis in an alternative imaging procedure such as 68Ga-SSTR-PET/CT or 18F-DOPA-PET/CT, including a contrast enhanced CT performed up to six months before study inclusion

Exclusion

  • Higher than grade 2 hematotoxicity (CTC \>2)
  • Persons with any kind of dependency on the investigator or employed by the sponsor or investigator