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

Mallinckrodt4 sites in 1 country150 target enrollmentJuly 2003

ConditionsSolid Tumors

InterventionsIndium In-111 pentetreotide

DrugsIndium In-111 pentetreotide

Overview

Phase: Phase 4
Intervention: Indium In-111 pentetreotide
Conditions: Solid Tumors
Sponsor: Mallinckrodt
Enrollment: 150
Locations: 4
Primary Endpoint: Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

August 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Mallinckrodt

Eligibility Criteria

Inclusion Criteria

•Males or females 18 years of age and older.
•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.
•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.
•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.
•Patients must have tumor localization by conventional imaging methods prior to enrollment (i.e., CT, MRI, US, angiogram).
•Patients referred for scintigraphy of solid tumors with a high suspicion of containing somatostatin receptor positive tissue.
•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 immunohistochemistry analysis.
•Patients with recurrent tumors or progressive tumors must have previous biopsy results documented, with previous biopsy tissue obtainable for immunohistochemistry analysis.

Exclusion Criteria

•Patients receiving Sandostatin LAR \< 21 days prior to dosing or Sandostatin Immediate Release (IM) \< 24 hours prior to dosing.
•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 accepted).
•Patients who are pregnant, breastfeeding or lactating.
•Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
•Patients scheduled to undergo any scintigraphy within 7 days prior to study participation or PET scanning within 24 hours prior to study participation.