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NM404 as an Imaging Agent in Patients With NSCLC

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ClinicalTrials.gov Identifier: NCT00582283
Recruitment Status : Active, not recruiting
First Posted : December 28, 2007
Last Update Posted : February 12, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cellectar Biosciences, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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).


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: I124-NM404 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: NM404 as an Imaging Agent in Patients With Non-small Cell Lung Cancer (NSCLC)
Study Start Date : January 2004
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Imaging characteristics [ Time Frame: 5 days ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

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 Posted: December 28, 2007    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

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