NM404 as an Imaging Agent in Patients With NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582283
• Other study ID #: CO02505
• Secondary ID: R21CA092412124I-
• Status: Completed
• Phase: Phase 1
• Start date: January 14, 2004
• Est. completion date: August 1, 2014

Study information

• Verified date: May 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 1, 2014
• Est. primary completion date: August 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• I124-NM404
I-124-NM404

Locations

Country	Name	City	State
United States	University of Wisconsin Carbone Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Cellectar Biosciences, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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