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
1. Males or females 18 years of age and older.
2. If female and of childbearing potential, patients must have a negative pregnancy test
within 24 hours of study drug administration. In addition, all female patients of
childbearing potential must agree to use a medically accepted method of contraception
throughout the study.
3. If deemed necessary by the Principal Investigator, patients entering the
pharmacokinetic population must be willing to be housed within the investigational
facility for a minimum of 24 hours following drug administration.
4. Patients (when able) or legally authorized representatives must have the ability to
understand the requirements of the study and provide written consent to participate
and agree to abide by the study requirements.
5. Patients must have tumor localization by conventional imaging methods prior to
enrollment (i.e., CT, MRI, US, angiogram).
6. Patients referred for scintigraphy of solid tumors with a high suspicion of
containing somatostatin receptor positive tissue.
7. Patients with first-time tumors must be scheduled for a tissue biopsy. A tissue
sample will be sent to the core laboratory for conventional histology and
8. Patients with recurrent tumors or progressive tumors must have previous biopsy
results documented, with previous biopsy tissue obtainable for immunohistochemistry
1. Patients receiving Sandostatin LAR < 21 days prior to dosing or Sandostatin Immediate
Release (IM) < 24 hours prior to dosing.
2. Patients who have received any investigational drug within 30 days of admission into
this study or plan to participate in a clinical study prior to the end of this
study's monitoring period (patients on a research protocol using an approved drug are
3. Patients who are pregnant, breastfeeding or lactating.
4. Patients with a medical condition, serious intercurrent illness, or extenuating
circumstance that would significantly decrease study compliance, including all
5. Patients scheduled to undergo any scintigraphy within 7 days prior to study
participation or PET scanning within 24 hours prior to study participation.