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

Completed · Phase 1

Conditions studied: Neuroendocrine Tumors, Heart Failure

In brief

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

Key facts

Study ID

NCT01730417

Run by

Bennett Chin

People needed

12

Starts

2009-11-01

Expected to finish

2011-07-01

Last updated by the study team

2012-11-21

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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