NM404 as an Imaging Agent in Patients With NSCLC
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|ClinicalTrials.gov Identifier: NCT00582283|
Recruitment Status : Active, not recruiting
First Posted : December 28, 2007
Last Update Posted : February 12, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: I124-NM404||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NM404 as an Imaging Agent in Patients With Non-small Cell Lung Cancer (NSCLC)|
|Study Start Date :||January 2004|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
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.
- Imaging characteristics [ Time Frame: 5 days ]
- Tumor accumulation and metabolic fate of NM404 in tissue [ Time Frame: 1 day ]
- Imaging Data [ Time Frame: 1, 2, 3 and 5-7 days ]
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): 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|