Non Small Cell Lung Cancer Clinical Trial
Official title:
NM404 as an Imaging Agent in Patients With Non-small Cell Lung Cancer (NSCLC)
Verified date | May 2019 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin Carbone Comprehensive Cancer Center | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | Cellectar Biosciences, Inc., National Cancer Institute (NCI) |
United States,
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 |
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