Overview

This trial is active, not recruiting.

Condition non small cell lung cancer
Treatment i124-nm404
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

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days.
i124-nm404
I-124-NM404

Primary Outcomes

Measure
Imaging characteristics
time frame: 5 days

Secondary Outcomes

Measure
Tumor accumulation and metabolic fate of NM404 in tissue
time frame: 1 day
Imaging Data
time frame: 1, 2, 3 and 5-7 days

Eligibility Criteria

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

Additional Information

Official title NM404 as an Imaging Agent in Patients With Non-small Cell Lung Cancer (NSCLC)
Principal investigator Anne M Traynor, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.
Location data was received from the National Cancer Institute and was last updated in August 2016.