Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG

This study has been completed.
Sponsor:
Collaborators:
Molecular Insights Pharmaceuticals
Information provided by (Responsible Party):
Bennett Chin, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01730417
First received: November 7, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane I 123 in normal human volunteers.


Condition Intervention Phase
Neuroendocrine Tumors
Heart Failure
Drug: no carrier added metaiodobenzylguanidine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG-Nanodosing: the Path to Higher Sensitivity and Lower Toxicity Radiopharmaceuticals

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Radiation dosimetry [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Radiation dosimetry was measured by imaging at several time points. Blood and urine samples were also collected to correlate with imaging parameters. Side effects were also assessed after drug administration.


Enrollment: 12
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation dosimetry
no carrier added metaiodobenzylguanidine
Drug: no carrier added metaiodobenzylguanidine
Sequential imaging was performed to determine radiation dosimetry of high specific activity 123I-mIBG
Other Name: Ultratrace

Detailed Description:

The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane I 123 in normal human volunteers. The low specific activity iobenguane I 123 has been shown to be useful for the detection and staging of neuroendocrine tumors in adults and children and imaging neuronal activity in the heart. The innovation in this proposal is through the use of patented solid phase technology to produce a proven diagnostic agent at extremely high specific activity to increase sensitivity and specificity and lower radiation exposure to normal organs without the pharmacologically active cold carrier compound. The FDA considers iobenguane labeled with two different isotopes of iodine [I-131 and I-123] as two distinct drugs requiring distinct regulatory applications.

To meet the required quality standards for the chemistry, manufacturing and controls component of an IND application, GMP quality polymer drug precursor is used to generate the Ultratrace diagnostic iodine-123 agent. Analytical methods were validated with the proposed final drug formulation to demonstrate the final drug does not interfere with tests used to define the identity, purity, and strength of the agent. The drug product was verified for apyrogenicity and sterility before human testing. The IND application was written and submitted to the FDA and the Duke Medical Center IRB. MIP produces clinical trial material, and will conduct human testing of the radioactive drug substance for safety and superiority compared to conventional iobenguane I 123 in normal healthy volunteers.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • normal healthy volunteers with written informed consent who understand and are willing to comply with protocol requirements
  • at least 21 years of age
  • if female, then not of childbearing potential as documented by history (e.g., tubal ligation or hysterectomy) or is post menopausal with a minimum 1 year without menses
  • if female of childbearing potential, a negative serum beta HCG pregnancy test within 24 hours prior to receiving iobenguane I 123
  • if female of childbearing potential, agrees to use an acceptable form of birth control, defined as abstinence or use of IUD, oral contraceptive, barrier and spermicide, or hormonal implant, throughout the study period
  • No existing predisposition to administration of thyroid blocking potassium iodide

Exclusion Criteria:

  • females who are nursing
  • documented history of significant allergy that required medical intervention to shellfish, X-ray contrast media, iodine/iodides, or iobenguane
  • administered a radioisotope within 5 effective half-lives of that radioisotope prior to study enrollment
  • abnormal screening laboratory studies (serum creatinine, SPOT, SGPT, total bilirubin as defined by standard laboratory reference ranges)
  • those who have received an investigational compound and/or medical device within 30 days of entering this study
  • pre-existing medical condition or circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study, (e.g. cancer, heart disease, or other medical conditions which potentially alter normal biodistribution)
  • is determined by the investigator that the patient is clinically unsuitable for the study
  • are taking medication which inhibits uptake of iobenguane I 123 within 2 weeks of enrollment, or tricyclic antidepressants or related drugs within 6 weeks of enrollment. Categories of medications include sympathomimetics, antihypertensives and cardiovascular agents, opioids, antipsychotics, tricyclic antidepressants, and medications as previously published
  • have participated in a clinical trial with an investigational drug in the past 30 days.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730417

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Bennett Chin
Molecular Insights Pharmaceuticals
Investigators
Principal Investigator: Bennett B Chin, MD Duke University
  More Information

Publications:
Chin BB, Grasfeder L, Femia F, Hillier S, Petry N, Armor T, Stubbs J, Stabin M, Babich J, Kronauge J. Phase 1 clinical trial results for high specific activity Ultratrace Iobenguane I 123. J Nucl Med. 2012;53:1516.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bennett Chin, Principal Investigator, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01730417     History of Changes
Other Study ID Numbers: Pro00019124 (MIP-CA130394-01), 5R44CA130394-03
Study First Received: November 7, 2012
Last Updated: November 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Phase 1
no carrier added metaiodobenzylguanidine
radiation dosimetry

Additional relevant MeSH terms:
Heart Failure
Neuroendocrine Tumors
Heart Diseases
Cardiovascular Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
3-Iodobenzylguanidine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on September 18, 2014