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NM404 as an Imaging Agent in Patients With NSCLC

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
I124-NM404
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin Carbone Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Diagnostic: iodine I-124 NM404 CT/PET scan

Arm Description

Patients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days.

Outcomes

Primary Outcome Measures

Qualitative Image Analysis of NSCLC tumors with 124I-NM404 imaging agent
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 Outcome Measures

Semi-quantitative lesion scoring to evaluate Tumor biodistribution
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).

Full Information

First Posted
December 19, 2007
Last Updated
May 20, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI), Cellectar Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00582283
Brief Title
NM404 as an Imaging Agent in Patients With NSCLC
Official Title
NM404 as an Imaging Agent in Patients With Non-small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 14, 2004 (Actual)
Primary Completion Date
August 1, 2014 (Actual)
Study Completion Date
August 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI), Cellectar Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic: iodine I-124 NM404 CT/PET scan
Arm Type
Other
Arm Description
Patients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days.
Intervention Type
Drug
Intervention Name(s)
I124-NM404
Intervention Description
I-124-NM404
Primary Outcome Measure Information:
Title
Qualitative Image Analysis of NSCLC tumors with 124I-NM404 imaging agent
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Semi-quantitative lesion scoring to evaluate Tumor biodistribution
Description
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).
Time Frame
up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne M Traynor, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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NM404 as an Imaging Agent in Patients With NSCLC

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