Heart/Mediastinal Ratio Study for Potential Equivalence of Heart/Mediastinal Ratios at One and Two Hours to the Traditional Heart/Mediastinal Ratio Obtained at Four Hours
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01448083|
Recruitment Status : Unknown
Verified September 2012 by Nuclear Medicine Consultants, Inc..
Recruitment status was: Recruiting
First Posted : October 7, 2011
Last Update Posted : September 18, 2012
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 and/or two hours after your diagnostic scan injection. If equivalent information to the conventional 4 hr H/M ratio could be collected by obtaining H/M ratios at 1 or 2 hour windows, it would greatly facilitate patient acceptance of the procedure since the requirements for obtaining a valid H/M 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 (Lugol's 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.
|Condition or disease||Intervention/treatment|
|Neuroendocrine Tumor||Other: Standard of care diagnostic MIBG scan for neuroendocrine tumor diagnosis.|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Study Start Date :||October 2011|
|Neuroendocrine tumor patients||
Other: Standard of care diagnostic MIBG scan for neuroendocrine tumor diagnosis.
Each subject will receive a 370 MBq (10 mCi ) (±10%) injection of I- 123 MIBG. Myocardial I-123 MIBG uptake will be quantitatively measured over time via planar imaging acquired at 15 minutes, one, two, four, and at 24 hours (the standard of care time point for NET patient imaging) post I-123MIBG injection.
- The heart/mediastinal ratio (H/M) at one or two hours post injection of AdreView™ (I-123 MIBG) in neuroendocrine tumor patients is equivalent to the standard 4 hr calculation. [ Time Frame: Approximately 10 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448083
|Contact: Maria M Chester, RN||(504) firstname.lastname@example.org|
|United States, Louisiana|
|Ochsner Medical Center - Kenner||Recruiting|
|Kenner, Louisiana, United States, 70065|
|Principal Investigator: Richard J Campeau, MD|