An Open-label, Single-dose, Single Arm, Single-center Clinical Trial of 64Cu(Copper)-DOTATATE (NETMedix™) PET-CT Scan for Imaging Patients With Known or Suspected Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

131797

This is an open-label, single-dose, single-arm, single-center imaging study using DOTATATE peptide, labelled with the 64Cu tracer.

2018-08-23

2019-03-23

2019-08-07

Completed

Early phase I

63

Inclusion Criteria: * Confirmed or suspicion of NET based on histology/ biopsy report. * Confirmed or suspicion of NET based on conventional imaging scans of affected area such as MRI and/or contrast enhanced CT and/or an FDG PET * CT scan and/or NaF PET-CT scan and/or OctreoScan® performed within 8 weeks prior to study date. Exclusion Criteria: * Pregnant, planning to be pregnant within the next two weeks * Inability to provide written consent. * Therapeutic use of any somatostatin analogue, including Sandostatin® long-acting and Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a subject is on Sandostatin® long-acting or Lanreotide, a wash-out period of 28 days is required before the injection of the study drug.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 63, 'type': 'ACTUAL'}}

2022-12-22