NM404 as an Imaging Agent in Patients With NSCLC

Phase 1

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: I124-NM404

• Registration Number: NCT00582283
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01-14
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-28
• Primary Completion: 2014-08-01
• Study Completion: 2014-08-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic: iodine I-124 NM404 CT/PET scan	I124-NM404	Patients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days.

Primary Outcome Measures

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

Name	Time	Method
Semi-quantitative lesion scoring to evaluate Tumor biodistribution	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).

Trial Locations

Locations (1)

University of Wisconsin Carbone Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States