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An Open-Label, Multi-Center, Phase 4 Study to Evaluate the Effect of Age (Geriatric) and Renal Function on the Safety, Efficacy (Sensitivity, Specificity) and Pharmacokinetics of OctreoScan in Patients Referred for Scintigraphy of All Solid Tumors With a High Suspicion of Containing Somatostatin Receptor Positive Tissue
The objective of this study was to evaluate the effect of age (geriatric) and renal function on the safety, efficacy and pharmacokinetics of OctreoScan at the recommended clinical dose in this patient population.
Details
| Lead sponsor | Mallinckrodt |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 150 |
| Start date | 2003-07 |
| Completion | 2005-08 |
Conditions
- Solid Tumors
Interventions
- Indium In-111 pentetreotide
Primary outcomes
- Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis — Through 24 hours post dose
Countries
United States