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OpenTrials
Completed

NCT Number: NCT00582283

NM404 as an Imaging Agent in Patients With NSCLC

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).

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Wisconsin Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I124-NM404

Drug

I-124-NM404

Primary outcomes

  1. Qualitative Image Analysis of NSCLC tumors with 124I-NM404 imaging agent

    Time frame: 5 days

    The objective of this protocol is to obtain preliminary data on imaging NSCLC tumors. Images with 124I-NM404 will be evaluated by a nuclear medicine consultant, who will be blind to the participants' clinical findings and other radiographic images. The nuclear medicine consultant will independently record his findings, and then compare his results with those obtained by conventional FDG-PET imaging that was done at baseline as part of this study. This comparison will be only qualitative.

Secondary outcomes

  1. Semi-quantitative lesion scoring to evaluate Tumor biodistribution

    Time frame: up to 7 days

    Images will be evaluated by physician who will be blinded to the participants' clinical or CT findings. The physician will score scans at the various time points for intensity of tumor uptake. A typical 0-3 scale will be used: 0 = no perceptible uptake, 1+ = uptake barely perceptible above background, 2+ = uptake clearly distinguishable above background, 3+ = intense uptake, much greater than surrounding normal structures (2+ and 3+ are considered abnormal or positive for lesion identification; 0 and 1+ are considered normal or negative for lesion identification).

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Cellectar Biosciences, Inc.
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2014
Study completion
2014
First posted
Dec 28, 2007
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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