NM404 as an Imaging Agent in Patients With NSCLC

This study has been suspended.

( Funding term completed. Final subject accrual for part 3 of study is on hold. )

First Received: December 19, 2007 No Changes Posted

Sponsors and Collaborators:	University of Wisconsin, Madison National Institutes of Health (NIH)
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00582283

Purpose

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. In addition, specific tumor accummulation and metabolic fate of 131-I-NM404 will be determined in NSCLC tumors collected in 5 patients. Lastly, the study will collect preliminary data on imaging NSCLC tumors in ten patients with evaluable disease.

Condition	Intervention
Non Small Cell Lung Cancer	Other: I-131-NM404

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Sodium iodide I 131

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Single Group Assignment
Official Title:	NM404 as an Imaging Agent in Patients With Non-Small Cell Lung Cancer (NSCLC)

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 ]

Estimated Enrollment:	19
Study Start Date:	January 2004
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A I-131-NM404	Other: I-131-NM404 I-131-NM404

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: Part 3

Histologically or cytologically documented NSCLC with clear evidence of disease
Disease is evaluable by CT scan
Karnofsky score >/= to 60
Adequate renal/hepatic function
Adequate blood cell count levels

Exclusion Criteria:

Concomitant infection
Other active cancers

Contacts and Locations

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

Locations

United States, Wisconsin
University of Wisconsin Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Anne M Traynor, MD

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin ( Anne Traynor )
Study ID Numbers:	H-2002-582, CO02505
Study First Received:	December 19, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00582283 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009