Advanced neuroendocrine tumours (NET), including medullary thyroid carcinoma (MTC), as well as gastroenteropancreatic and bronchopulmonary NET
Conditions
Interventions
Product Name: 68Ga-DOTA-MGS5
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 68Ga-DOTA-MGS5
Current Sponsor code: 68Ga-DOTA-MGS5
Other descriptive name: radiolabelled peptide analogue
Sponsors
Medizinische Universität Innsbruck
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Clinical safety and tolerability of intravenous administration of 68Ga-DOTA-MGS5 - Whole-body distribution and dosimetry;Timepoint(s) of evaluation of this end point: Completion of 12 patients;Secondary Objective: - Preliminary targeting properties of 68Ga-DOTA-MGS5 in patient with advanced MTC and other NET - Comparison of the targeting properties with other standard imaging modalities (18F-DOPA-PET/CT or 68Ga-SSTR-PET/CT including a contrast enhanced CT performed up to six months before study inclusion) - Description of the overall, positive and negative agreement on a lesion-bylesion basis as well as on a patient basis of 68Ga-DOTA-MGS5 PET/CT (low dose CT) relative to the standard imaging procedures overall and for each tumour type;Primary end point(s): - Standard safety and tolerability parameters (clinical monitoring, laboratory, ECG) - Any serious adverse reactions (SAR) and any suspected unexpected serious adverse reaction (SUSAR) related to the study drug as determined by clinically relevant changes of physiological parameters (blood pressure, heart rate, ECG findings) defined by the CTCAE v5.0 - Tolerability and safety of the administration of a diagnostic dose of 68Ga-DOTA-MGS5 in patients with advanced MTC and other NET as determined by absence of increased number of SAR and SUSAR compared to other peptide-based radiotracers - Generation of time activity curves and calculation of residence times of 68Ga-DOTA-MGS5 in normal organs and tumour lesions - Calculation of absorbed tumour-to-organ doses and effective whole-body dose of 68Ga-DOTA-MGS5 - Quantification of urinary excretion of 68Ga-DOTA-MGS5 - Calculation of half-life of 68Ga-DOTA-MGS5 in blood | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Description of tumour lesions (number of lesions, uptake per lesion) and comparison with known tumour lesions - Preliminary comparison with standard imaging modalities such as 18F-DOPA-PET/CT and 68Ga-SSTRPET/CT (number of lesions, uptake per lesion) - Description of the overall, positive and negative agreement on a lesion-by-lesion basis as well as on a patient basis of 68Ga-DOTA-MGS5 PET/CT relative to the standard imaging procedures overall and for each tumour type;Timepoint(s) of evaluation of this end point: Completion of 12 patients | — |
Countries
Austria
Contacts
Public ContactChefsekretariat
Universitätsklinik für Nuklearmedizin
Outcome results
None listed