Clinical trial · Interventional
NM404 as an Imaging Agent in Patients With NSCLC
NM404 as an Imaging Agent in Patients With Non-small Cell Lung Cancer (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| I124-NM404 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Diagnostic: iodine I-124 NM404 CT/PET scan
- description
- Patients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days.
- interventionNames
- Drug: I124-NM404
Primary outcomes (1)
- measure
- Qualitative Image Analysis of NSCLC tumors with 124I-NM404 imaging agent
- timeFrame
- 5 days
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available