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NM404 as an Imaging Agent in Patients With NSCLC

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00582283
First Posted: December 28, 2007
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Cellectar Biosciences, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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 (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 ]

Secondary Outcome Measures:
  • Tumor accumulation and metabolic fate of NM404 in tissue [ Time Frame: 1 day ]
  • Imaging Data [ Time Frame: 1, 2, 3 and 5-7 days ]

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
I-124-NM404

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Cancer Institute (NCI)
Cellectar Biosciences, Inc.
Investigators
Principal Investigator: Anne M Traynor, MD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582283     History of Changes
Other Study ID Numbers: CO02505
R21CA092412 ( U.S. NIH Grant/Contract )
124I-CLR1404 ( Other Grant/Funding Number: Novelos Therapeutics )
First Submitted: December 19, 2007
First Posted: December 28, 2007
Last Update Posted: January 26, 2017
Last Verified: January 2017

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