Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan

15-06-274

The primary goal of the analysis is to estimate the diagnostic accuracy of Gallium 68 (68Ga) -DOTATOC PET/CT for detecting neuroendocrine tumors (NETs) compared to conventional imaging techniques such as Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT). Participants with histologically and/or clinically confirmed and/or suspected NET will be enrolled.

2016-05-16

2017-03-01

2017-03-01

Completed

Early phase I

11

Inclusion Criteria: * Signed informed consent. * Patients of either gender, aged ≥18 years. * Karnofsky status ≥60. * Life expectancy of at least 12 weeks. * Histologically and/or clinically confirmed and/or suspicious of NET. * A diagnostic CT or MRI of the tumour region or suspected area within the previous 12 weeks prior to dosing day is available. * Somatostatin-analogue scintigraphy scan with result (positive or negative) within the last 12 weeks. * Recent Blood test results up to 4-6 weeks as follows: 1. White Blood Cell (WBC): \>2\*109/L 2. Haemoglobin: \>8.0g/Dl 3. Platelets: \>50x109/L 4. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline phosphatase (AP) each less than, or equal to, 5 times its Upper Limit of Normal (ULN) 5. Bilirubin less than, or equal to, three times its ULN * Serum creatinine: within normal range or \<120μmol/L for patients aged 60 years or older. * Negative pregnancy test in women capable of child-bearing. Exclusion Criteria: * Known hypersensitivity to Gallium 68, DOTATOC or to any of the excipients of 68Ga-DOTATOC. * Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (Long Acting Release) (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug. * Pregnant or breast-feeding women. * Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

2023-05-09