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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

This study has been terminated.
(Enrollment was difficult)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00944372
First Posted: July 23, 2009
Last Update Posted: September 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mallinckrodt
  Purpose
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.

Condition Intervention Phase
Solid Tumors Drug: Indium In-111 pentetreotide Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: July 2003
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944372


Locations
United States, Florida
University of Miami, Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Iowa
University of Iowa Medical Center
Iowa City, Iowa, United States, 52242
United States, Louisiana
Louisiana State University, Division of Hem/Onc
New Orleans, Louisiana, United States, 70112
United States, Pennsylvania
Hospital of University of Pennsylvania, Division of Nuclear Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Mallinckrodt
  More Information

Responsible Party: James Brodack, Ph.D., Mallinckrodt
ClinicalTrials.gov Identifier: NCT00944372     History of Changes
Other Study ID Numbers: 0050-02-763
First Submitted: July 21, 2009
First Posted: July 23, 2009
Last Update Posted: September 9, 2016
Last Verified: September 2016

Keywords provided by Mallinckrodt:
Tumor
somatostatin receptor

Additional relevant MeSH terms:
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs