Status:
COMPLETED
68Ga-DOTA-MGS5 PET/CT in Patients With Advanced Neuroendocrine Tumours
Lead Sponsor:
Medical University Innsbruck
Collaborating Sponsors:
Novartis
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 (CC...
Detailed Description
This is a monocentric, open-label, single dose diagnostic Phase I/IIa study. Due to the very limited number of patients and the rare nature of the disease the study was designed as a combination of ph...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06155994
Start Date
January 20 2021
End Date
June 30 2023
Last Update
December 5 2023
Active Locations (1)
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1
Department of Nuclear Medicine, Medical University of Innsbruck
Innsbruck, Austria, 6020