68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs)
Completed · Not applicable
Conditions studied: Neuroendocrine Carcinoma
In brief
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.
Key facts
- Study ID
- NCT01879657
- Run by
- Radio Isotope Therapy of America
- People needed
- 169
- Starts
- 2013-03-01
- Expected to finish
- 2017-12-05
- Last updated by the study team
- 2025-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Radio- Isotope Therapy of America — Houston, Texas, United States
Full record on ClinicalTrials.gov
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