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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA092412 | U.S. NIH Grant/Contract | View source | |
| 124I-CLR1404 | Other Grant/Funding Number | Novelos Therapeutics |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Cellectar Biosciences, Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic: iodine I-124 NM404 CT/PET scan | Other | Patients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I124-NM404 | Drug | I-124-NM404 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria: Part 3
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne M Traynor, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| up to 7 days |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |