Ignite Creation Date:
2024-05-06 @ 1:06 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01730417
Status:
COMPLETED
Last Update Posted:
2012-11-21
First Post:
2012-11-07
Brief Title:
Phase I Study of the Safety Distribution and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG
Sponsor:
Bennett Chin
Organization:
Duke University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mIBG
Brief Summary:
The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane I 123 in normal human volunteers
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R44CA130394-03 | NIH | None | httpsreporternihgovquickSearch5R44CA130394-03 |