NM404 as an Imaging Agent in Patients With NSCLC

Study Overview
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Brief Summary
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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).

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

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: I124-NM404


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diagnostic: iodine I-124 NM404 CT/PET scan<br>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<br>* I-124-NM404<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | up to 7 days |