Study to Evaluate the Effect of Age (Geriatric) and Kidne... | NCT00944372

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental	Control, age greater than or equal to 18 with normal renal function	Drug: Indium In-111 pentetreotide
Group 2	Experimental	Age 18 to less than 65 with mild renal impairment	Drug: Indium In-111 pentetreotide
Group 3	Experimental	Age 18 to less than 65 with moderate to severe renal impairment	Drug: Indium In-111 pentetreotide
Group 4	Experimental	Age 18 to less than 65 with end stage renal impairment	Drug: Indium In-111 pentetreotide
Group 5	Experimental	Age 65 to less than 75 with mild renal impairment	Drug: Indium In-111 pentetreotide
Group 6	Experimental	Age 65 to less than 75 with moderate to severe renal impairment

Name	Type	Description	Arm Group Labels	Other Names
Indium In-111 pentetreotide	Drug	Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide	Group 1 Group 10 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis		Through 24 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive using previously biopsied tissue for immunohistochemistry analysis		Through 24 hours post dose

Eligibility Module

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.

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami, Jackson Memorial Hospital		Miami	Florida	33136	United States
University of Iowa Medical Center

ID	Term
C081788	pentetreotide
C000615551	Indium-111