Status:
COMPLETED
68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs)
Lead Sponsor:
Radio Isotope Therapy of America
Collaborating Sponsors:
Radiomedix, Inc.
Excel Diagnostics and Nuclear Oncology Center
Conditions:
Neuroendocrine Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 imag...
Detailed Description
The number of lesions that could be identified clearly as single foci will be determined for each patient. The same anatomic areas will be imaged with 68Ga-DOTATATE PET and 111In-penteoctreotide Scint...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2017
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT01879657
Start Date
March 1 2013
End Date
December 5 2017
Last Update
August 6 2025
Active Locations (1)
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1
Radio- Isotope Therapy of America
Houston, Texas, United States, 77042