Iodine I 124 NM404 CT/PET in Imaging Patients with Stage IV or Recurrent Non-Small Cell Lung Cancer
This trial is active, not recruiting.
|Condition||non small cell lung cancer|
|Sponsor||University of Wisconsin, Madison|
|Collaborator||National Cancer Institute (NCI)|
|Start date||January 2004|
|End date||May 2018|
|Trial size||21 participants|
|Trial identifier||NCT00582283, 124I-CLR1404, CO02505, R21CA092412|
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).
Patients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days.
time frame: 5 days
Tumor accumulation and metabolic fate of NM404 in tissue
time frame: 1 day
time frame: 1, 2, 3 and 5-7 days
Male or female participants at least 18 years old.
Inclusion Criteria: Part 3 - Histologically or cytologically documented NSCLC with measurable of disease - Disease is evaluable by CT scan - At least 18 years old. Women cannot be pregnant or breastfeeding - Karnofsky score >/= to 60 - Adequate renal/hepatic function - Adequate blood cell count levels Exclusion Criteria: - Concomitant infection - Other active cancers
|Official title||NM404 as an Imaging Agent in Patients With Non-small Cell Lung Cancer (NSCLC)|
|Principal investigator||Anne M Traynor, MD|
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