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Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors

This study has been completed.
Excel Diagnostic Imaging Clinics
CHI St. Luke's Health, Texas
Information provided by (Responsible Party):
Ebrahim Delpassand, Radio Isotope Therapy of America Identifier:
First received: March 1, 2007
Last updated: April 27, 2017
Last verified: April 2017
The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.

Condition Intervention Phase
Neuroendocrine Tumors
Drug: Indium-111 pentetreotide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.

Resource links provided by NLM:

Further study details as provided by Ebrahim Delpassand, Radio Isotope Therapy of America:

Primary Outcome Measures:
  • Radiological response [ Time Frame: 3 months after each therapy cycle ]

Enrollment: 200
Study Start Date: August 2005
Study Completion Date: December 29, 2015
Primary Completion Date: August 30, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indium-111 pentetreotide
4 cycles of 500 mCi treatments every 10-12 weeks
Drug: Indium-111 pentetreotide
4 cycles of 500 mCi treatments every 10-12 weeks
Other Name: (Neuroendomedix)


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

Inclusion Criteria:

  • Patients must have received first line standard chemotherapy and/or radiation therapy for neuroendocrine malignancy in the past and failed the therapy.
  • Patients must have evidence of residual multifocal active tumor.
  • All patients must sign an informed consent indicating the awareness of the investigational nature of the studies involved.
  • All patients must have a Karnofsky performance status of at least 60.
  • Patients must be greater than 18 years of age.
  • Patients must have measurable and/or followable disease based on either clinical or radiologic exam.
  • Sensitivity to Indium-111 pentetreotide or any of its components is an absolute contraindication to participation in this trial.
  • An absolute contraindication is pregnancy as evidenced by the clinical condition, a positive pregnancy test (B-HCG or pelvic ultrasound).
  • If patients have received prior radionuclide therapy of the same product, there must be documented response to that therapy and/or residual active stable disease.

Exclusion Criteria:

  • Karnofsky performance status of 50 or less.
  • Patients who are unable to give informed consent.
  • Patients under 18 years of age. There will be no upper age discrimination.
  • Patients who are pregnant or those potentially pregnant subjects not willing to practice effective contraceptive techniques during the study period.
  • Patients with renal insufficiency as defined by a calculated creatinine clearance (based on age, weight and serum creatinine) of 39.9 ml/min or less.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00442533

United States, Texas
Excel Diagnostic Imaging Clinics
Houston, Texas, United States, 77042
St. Lukes Episcopal Hospital
Houston, Texas, United States, 77225-0269
Sponsors and Collaborators
Radio Isotope Therapy of America
Excel Diagnostic Imaging Clinics
CHI St. Luke's Health, Texas
Principal Investigator: Ebrahim Delpassand, M.D. RITA Foundation
  More Information

Responsible Party: Ebrahim Delpassand, President and CEO, Radio Isotope Therapy of America Identifier: NCT00442533     History of Changes
Other Study ID Numbers: 06-2247
Study First Received: March 1, 2007
Last Updated: April 27, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Ebrahim Delpassand, Radio Isotope Therapy of America:
Islet Cell Cancer

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2017