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

• Status: Completed
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University Innsbruck
• Collaborator: Novartis

Criteria

Inclusion Criteria:

• ≥18 years, men and women

• Understanding and provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures

• Karnofsky performance status >70

• 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

• 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

• Male subjects must-agree to use condoms throughout the study period and for 1 month after study termination if their partner is of childbearing potential and is using no contraception. They agree not to donate semen during study period and for 1 month after study termination.

• Women of childbearing potential (WOCBP) must have a negative urine/serum pregnancy test. WOCBP who are sexually active, agree to use highly-effective means of contraception during the study and for at least 6 months post-study treatment. Allowed are accepted and effective non-hormonal methods of contraception and sexual abstinence or vasectomised partners (>3 months previously). Vasectomy has to be confirmed by two negative semen analyses.

Exclusion Criteria:

• Other known co-existing malignancies except patients with a history of malignant tumours in complete remission >3 years, with no evidence of recurrence <5 years

• Participation in any other investigational trial within 3 months of study entry

• Treatment with tyrosine kinase inhibitors within 1 month before study entry

• Organ allograft requiring immunosuppressive therapy

• Renal insufficiency with an eGFR <30 mL/min/1.72m2

• Higher than grade 2 hematotoxicity (CTC >2)

• Clinically abnormal ECG (signs of ischemia, high grade ventricular arrhythmia, high grade supra-ventricular arrhythmia)

• Pregnancy, breast-feeding

• Patients with concurrent illnesses or severe infectious diseases that might preclude study completion

• Patients with bladder outflow obstruction or unmanageable urinary incontinence

• Known hypersensitivity to gallium-68 or to any of the excipients of DOTA-MGS5

• Any condition that precludes raised arms position for prolonged imaging purposes

• Prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide used on such radiopharmaceutical

• Clinically significant illness or clinically relevant trauma within 3 weeks before the administration of the investigational product

• Persons with any kind of dependency on the investigator or employed by the sponsor or investigator

• Persons held in an institution by legal or official order