Non Small Cell Lung Cancer
Conditions
Brief 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).
Interventions
DRUGI124-NM404
I-124-NM404
Sponsors
National Cancer Institute (NCI)
Cellectar Biosciences, Inc.
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Image Analysis of NSCLC tumors with 124I-NM404 imaging agent | 5 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Semi-quantitative lesion scoring to evaluate Tumor biodistribution | up to 7 days | 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). |
Countries
United States
Outcome results
None listed