Trial | NCT00582283  Report issue

Title

NM404 as an Imaging Agent in Patients With NSCLC
NM404 as an Imaging Agent in Patients With Non-small Cell Lung Cancer (NSCLC)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    21
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).
Study Started
Jan 14
2004
Primary Completion
Aug 01
2014
Study Completion
Aug 01
2014
Last Update
May 22
2019

Drug I124-NM404

I-124-NM404

Diagnostic: iodine I-124 NM404 CT/PET scan Other

Patients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days.

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
No Results Posted