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
21 Years
85 Years
Both
Neuroendocrine Tumors, Heart Failure
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Radiation dosimetry
Outcome Description:
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.
Outcome Time Frame:
2 weeks
Safety Issue:
Yes
Principal Investigator
Bennett B Chin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Duke University
Authority:
United States: Food and Drug Administration
Study ID:
Pro00019124 (MIP-CA130394-01)
NCT ID:
NCT01730417
Start Date:
November 2009
Completion Date:
July 2011
Related Keywords:
- Neuroendocrine Tumors
- Heart Failure
- Phase 1
- no carrier added metaiodobenzylguanidine
- radiation dosimetry
- Heart Failure
- Neuroendocrine Tumors
Name | Location |
|---|---|
| Duke University Medical Center | Durham, North Carolina 27710 |
