NM404 as an Imaging Agent in Patients With NSCLC
Non Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Study Type
Study Phase
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Name: I-131-NM404 Type: Other
Name: I124-NM404 Type: Drug
Overall Status
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
University of Wisconsin Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Status: Recruiting
Contact: Anne Traynor, MD - 608-262-5092
Start Date
January 2004
Completion Date
May 2018
University of Wisconsin, Madison
University of Wisconsin, Madison
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page