Minigastrin derivative labelled with radioactive Gallium-68, for the diagnosis of advanced neuroendocrine tumours
- Conditions
- Advanced neuroendocrine tumours (NET), including medullary thyroid carcinoma (MTC), as well as gastroenteropancreatic and bronchopulmonary NETTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2020-003932-26-AT
- Lead Sponsor
- Medizinische Universität Innsbruck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 12
- =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 gastroenteropancreatic and bronchopulmonary NET with known metastases
- Patients with an advanced stage of disease as documented by local or distant metastasis in alternative imaging procedure such as 68Ga-SSTR-PET/CT or 18FDOPA-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 the 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 period and for at least 6 months poststudy 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
- 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 supraventricular 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 or
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method