NM404 as an Imaging Agent in Patients With NSCLC
Conditions
Non Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: I-131-NM404 Type: Other
Name: I124-NM404 Type: Drug
Overall Status
Recruiting
Summary
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
Location
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
Sponsors
University of Wisconsin, Madison
Source
University of Wisconsin, Madison
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page