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NCT00582283 · ClinicalTrials.gov registry record · Phase 1

NM404 as an Imaging Agent in Patients With NSCLC

A Phase 1 study, sponsored by University of Wisconsin, Madison.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target

NCT00582283: Completed Phase 1 study, sponsored by University of Wisconsin, Madison.

NCT00582283 is a Phase 1 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00582283, a Phase 1 study, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study 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).

Primary Outcome

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.

Interventions

  • DRUG I124-NM404

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2004-01-14
Est. Completion 2014-08-01
Phase Phase 1
University of Wisconsin, Madison

1,039 total trials

What the finished NCT00582283 record still lists

NCT00582283 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 1 intervention - of which I124-NM404 is the first listed.

NCT00582283 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00582283 about?

NCT00582283 is a clinical study titled "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-NM...

What is the current status of trial NCT00582283?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2004-01-14. Estimated completion is 2014-08-01.

What interventions are being tested in trial NCT00582283?

The interventions under investigation include: I124-NM404 (DRUG).

Who is sponsoring clinical trial NCT00582283?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00582283's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00582283, the US trial registry maintained by the National Library of Medicine. NCT00582283 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.