Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00582283 | NM404 as an Imaging Agent in Patients With NSCLC | PHASE1 | COMPLETED | 21 | — | — | Jan 14, 2004 | Aug 1, 2014 | May 22, 2019 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| I124-NM404 | DRUG | I-124-NM404 |
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 le...