NM404 as an Imaging Agent in Patients With NSCLC

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Cellectar Biosciences, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
First received: December 19, 2007
Last updated: September 17, 2015
Last verified: September 2015

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).

Condition Intervention
Non Small Cell Lung Cancer
Drug: I124-NM404

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: NM404 as an Imaging Agent in Patients With Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Imaging characteristics [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor accumulation and metabolic fate of NM404 in tissue [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Imaging Data [ Time Frame: 1, 2, 3 and 5-7 days ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: January 2004
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diagnostic: iodine I-124 NM404 CT/PET scan
Patients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days.
Drug: I124-NM404


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-small cell lung cancer treated at University of Wisconsin Hospital and Clinics

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00582283

United States, Wisconsin
University of Wisconsin Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Cellectar Biosciences, Inc.
Principal Investigator: Anne M Traynor, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582283     History of Changes
Other Study ID Numbers: CO02505  R21CA092412  124I-CLR1404 
Study First Received: December 19, 2007
Last Updated: September 17, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on February 11, 2016