68-Ga-DOTATATE PET-CT Scan for Diagnosis and Staging of Neuroendocrine Tumors

• Status: Completed
• Trial end date: 2017-12-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radio Isotope Therapy of America
• Collaborators: Excel Diagnostics and Nuclear Oncology Center; RadioMedix; Radiomedix, Inc.

Criteria

Inclusion Criteria:

• Patients of either gender, aged at least 18 years.

• Karnofsky status equal or greater than 60.

• Life expectancy of at least 12 weeks.

• Histologically and/or clinically confirmed and/or suspicious of NET.

• Somatostatin-analogue scintigraphies scan with result (positive or negative) within the last 4 weeks.

• Recent Blood test results up to 2-3 weeks as follows:(WBC:equal/higher 2*109/L; Haemoglobin: equal/higher 8.0g/Dl; Platelets: equal/higher 50x109/L; ALT, AST, AP: equal/lower 5 times ULN; Bilirubin: equal/lower 3 times 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 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.