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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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


Inclusion Criteria:



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
immunohistochemistry analysis.

8. Patients with recurrent tumors or progressive tumors must have previous biopsy
results documented, with previous biopsy tissue obtainable for immunohistochemistry
analysis.

Exclusion Criteria:

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
accepted).

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
prescribed follow-up.

5. Patients scheduled to undergo any scintigraphy within 7 days prior to study
participation or PET scanning within 24 hours prior to study participation.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis

Outcome Time Frame:

Through 24 hours post dose

Safety Issue:

Yes

Principal Investigator

Herbert Neuman, MD

Investigator Role:

Study Director

Investigator Affiliation:

Mallinckrodt

Authority:

United States: Food and Drug Administration

Study ID:

0050-02-763

NCT ID:

NCT00944372

Start Date:

July 2003

Completion Date:

August 2005

Related Keywords:

  • Solid Tumors
  • Tumor
  • somatostatin receptor

Name

Location

University of Iowa Medical CenterIowa City, Iowa  52242
University of Miami, Jackson Memorial HospitalMiami, Florida  33136
Louisiana State University, Division of Hem/OncNew Orleans, Louisiana  70112
Hospital of University of Pennsylvania, Division of Nuclear MedicinePhiladelphia, Pennsylvania  19104