Phase
Condition
Abdominal Cancer
Neuroendocrine Carcinoma
Digestive System Neoplasms
Treatment
111In-pentetreotide OctreoScan
PET/CT
68Ga-DOTATATE
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed informed consent
Subjects of either sex, aged ≥18 years
Histologically and/or clinically confirmed and/or suspected NET and/or A diagnosticimaging study including but not limited to CT or MRI or FDG PET/CT, NaF PET/CT, bonescan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks ofdosing day
Recent Blood test results (within 2-4 weeks predose) as WBC: ≥2 x 109/L,Haemoglobin: ≥8.0 g/dL, Platelets: ≥50 x 109/L, ALT, AST, AP:≤ 5 times ULN [ ULN forALT, AST and AP is 70, 20 and 20 Units/I respectively], Bilirubin: ≤3 times ULN [ULNfor total bilirubin is 1.3mg/dL]
Serum creatinine: Serum creatinine: <170 μmol/L
egative pregnancy test in women capable of child-bearing
Exclusion
Exclusion Criteria:
Known hypersensitivity to DOTA, to 68Gallium, to Octreotate or to any of theexcipients of 68Ga-DOTATATE
Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is onSandostatin® LAR a wash-out phase of 28 days is required before the injection of thestudy drug
Pregnant or breast-feeding women
Current somatic or psychiatric disease/condition that may interfere with theobjectives and assessments of the study
Study Design
Study Description
Connect with a study center
Radio- Isotope Therapy of America
Houston, Texas 77042
United StatesSite Not Available

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