Phase I/IIa study to evaluate the safety, tolerability, whole-body distribution, and preliminary diagnostic performance of a novel 68Ga-labelled minigastrin analogue in patients with advanced neuroendocrine tumours

Medizinische Universität Innsbruck0 sites12 target enrollmentDecember 1, 2020

ConditionsAdvanced neuroendocrine tumours (NET), including medullary thyroid carcinoma (MTC), as well as gastroenteropancreatic and bronchopulmonary NET Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced neuroendocrine tumours (NET), including medullary thyroid carcinoma (MTC), as well as gastroenteropancreatic and bronchopulmonary NET
Sponsor: Medizinische Universität Innsbruck
Enrollment: 12
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 1, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Medizinische Universität Innsbruck

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 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:

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 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