Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT06155994
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06155994
Study Brief:
Protocol Section:
NCT06155994