68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs) (NCT01879657) | Clinical Trial Compass
CompletedNot Applicable
68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs)
United States169 participantsStarted 2013-03-01
Plain-language summary
To evaluate the concordance and discordance between results of 68Ga-DOTATATE PET-CT scan and OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers and other imaging modalities like CT scan/MRI as gold standard.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Signed informed consent
* Subjects of either sex, aged ≥18 years
* Histologically and/or clinically confirmed and/or suspected NET and/or A diagnostic imaging study including but not limited to CT or MRI or FDG PET/CT, NaF PET/CT, bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing 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 \[ ULN for ALT, AST and AP is 70, 20 and 20 Units/I respectively\], Bilirubin: ≤3 times ULN \[ULN for total bilirubin is 1.3mg/dL\]
* Serum creatinine: Serum creatinine: \<170 μmol/L
* egative pregnancy test in women capable of child-bearing
Exclusion Criteria:
* Known hypersensitivity to DOTA, to 68Gallium, to Octreotate or to any of the excipients of 68Ga-DOTATATE
* Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (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
What they're measuring
1
Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique
Timeframe: SOT within 28 days before 68Ga-DOTATATE PET/CT scan