NM404 as an Imaging Agent in Patients With NSCLC
This study seeks to determine imaging characteristics of radiolabelled 131-I-NM404 in ten patients with cancer, including calculations of PKs, radiation dosimetry, biodistribution, and optimal imaging times (part 1 - complete).
In addition, specific tumor accumulation and metabolic fate of 131-I-NM404 will be determined in NSCLC tumors collected in 5 patients (part 2 - complete). Lastly, the study will collect preliminary data on imaging NSCLC tumors in up to 12 patients with evaluable disease (part 3 - ongoing).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||NM404 as an Imaging Agent in Patients With Non-small Cell Lung Cancer (NSCLC)|
- Imaging characteristics [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Tumor accumulation and metabolic fate of NM404 in tissue [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Imaging Data [ Time Frame: 1, 2, 3 and 5-7 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Diagnostic: iodine I-124 NM404 CT/PET scan
Patients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582283
|United States, Wisconsin|
|University of Wisconsin Carbone Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Anne M Traynor, MD||University of Wisconsin, Madison|