Study to Evaluate the Effect of Age (Geriatric) and Kidney Function on the Safety, Efficacy and Pharmacokinetics of OctreoScan in Patients Who Have New or Recurrent Tumors

September 8, 2016 updated by: Mallinckrodt

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami, Jackson Memorial Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University, Division of Hem/Onc
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of University of Pennsylvania, Division of Nuclear Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Control, age greater than or equal to 18 with normal renal function
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 2
Age 18 to less than 65 with mild renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 3
Age 18 to less than 65 with moderate to severe renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 4
Age 18 to less than 65 with end stage renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 5
Age 65 to less than 75 with mild renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 6
Age 65 to less than 75 with moderate to severe renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 7
Age 65 to less than 75 with end stage renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 8
Age greater than or equal to 75 with mild renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 9
Age greater than or equal to 75 with moderate to severe renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 10
Age greater than or equal to 75 with end stage renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mallinckrodt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

July 21, 2009

First Submitted That Met QC Criteria

July 22, 2009

First Posted (Estimate)

July 23, 2009

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0050-02-763

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Solid Tumors

Clinical Trials on Indium In-111 pentetreotide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe