NM404 as an Imaging Agent in Patients With NSCLC

NCT ID: NCT00582283

Last Updated: 2019-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-14

Study Completion Date

2014-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diagnostic: iodine I-124 NM404 CT/PET scan

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

Group Type OTHER

I124-NM404

Intervention Type DRUG

I-124-NM404

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

I124-NM404

I-124-NM404

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Cellectar Biosciences, Inc.

INDUSTRY

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anne M Traynor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Wisconsin Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R21CA092412

Identifier Type: NIH

Identifier Source: secondary_id

View Link

124I-CLR1404

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CO02505

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.