Ignite Creation Date:
2024-05-05 @ 11:55 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01448083
Status:
UNKNOWN
Last Update Posted:
2012-09-18
First Post:
2011-10-03
Brief Title:
HeartMediastinal Ratio Study for Potential Equivalence of HeartMediastinal Ratios at One and Two Hours to the Traditional HeartMediastinal Ratio Obtained at Four Hours
Sponsor:
Nuclear Medicine Consultants Inc
Organization:
Nuclear Medicine Consultants Inc
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2012-09
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The purpose of this study is to determine if the measurement with a standard nuclear camera of radioactivity normally present in the nervous system of your heart at four hours after the injection of radioactive drug for your diagnostic I-123 MIBG scan is any different than radioactivity measured in your heart at one andor two hours after your diagnostic scan injection If equivalent information to the conventional 4 hr HM ratio could be collected by obtaining HM ratios at 1 or 2 hour windows it would greatly facilitate patient acceptance of the procedure since the requirements for obtaining a valid HM ratio would be considerably less time-consuming
One hour before being injected with the drug I-123 MIBG for your MIBG scan you will be given a standard dose of non-radioactive iodine Lugols solution to block your thyroid from receiving the small amount of radiation that is a normal part of the MIBG scan You will then be injected with MIBG and you will have 10 minute pictures of your chest at 15 minutes 1 hour 2 hours and 4 hours in addition to the standard 24 hour pictures These pictures will be taken in the Nuclear Medicine Section Department of Radiology at Ochsner Medical Center-Kenner The experimental research part of this study is having the extra 10-minute pictures of your chest at 15 minutes 1 hour 2 hours and 4 hours Normally pictures are only taken 24 hours after the injection Therefore the research is limited to the four extra pictures taken and involve no additional injections or I-123 drug beyond that you will be receiving regardless of whether you are part of this research
One hour before being injected with the drug I-123 MIBG for your MIBG scan you will be given a standard dose of non-radioactive iodine Lugols solution to block your thyroid from receiving the small amount of radiation that is a normal part of the MIBG scan You will then be injected with MIBG and you will have 10 minute pictures of your chest at 15 minutes 1 hour 2 hours and 4 hours in addition to the standard 24 hour pictures These pictures will be taken in the Nuclear Medicine Section Department of Radiology at Ochsner Medical Center-Kenner The experimental research part of this study is having the extra 10-minute pictures of your chest at 15 minutes 1 hour 2 hours and 4 hours Normally pictures are only taken 24 hours after the injection Therefore the research is limited to the four extra pictures taken and involve no additional injections or I-123 drug beyond that you will be receiving regardless of whether you are part of this research
Detailed Description:
None
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