Clinical trial · Interventional
First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy
IFN-y PET Imaging: Bench to Bedside
NCT06439914CI-TRIAL-00105252recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The goal of this clinical trial is to investigate the use of \[89Zr\]Zr-DFO-emapalumab as an IFN-γ PET imaging agent to detect lesions and response to therapy among treatment-naïve non-small cell lung cancer (NSCLC) patients. PET scans following the imaging agent will be completed prior to and about 30 days after starting immunotherapy.
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 |
|---|---|---|---|
| [89Zr]Zr-DFO-emapalumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [89Zr]Zr-DFO-emapalumab
- description
- Radiotracer \[89Zr\]Zr-DFO-emapalumab injection
- interventionNames
- Drug: [89Zr]Zr-DFO-emapalumab
Primary outcomes (3)
- measure
- peak Standard Uptake Value (SUVpeak)
- timeFrame
- Up to Day 45
- description
- Descriptively summarize at baseline and post-immunotherapy treatments.
- measure
- mean Standard Uptake Value (SUVmean)
- timeFrame
- Up to Day 45
- description
- Descriptively summarize at baseline and post-immunotherapy treatments.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion * Prior histologic or cytologic diagnosis of non-small cell lung cancer. * FDG PET done within 2 months of the baseline imaging, as part of standard-of-care. * measurable disease by RECIST 1.1 with at least one lesion of at least 2 cm in a region of the body that can be imaged by PET (e.g.,outside of the liver) * must be able to lie still for the tests. Their girth and weight must be suitable to enter the gantry, which varies per tomograph. * must be \>18 years old. * Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the cancer center. * Physical exam, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST, and ALT) must be done within 28 days prior to PET imaging Exclusion * No prior immunotherapy for current stage of NSCLC (Non Small Cell Lung Cancer). Immunotherapy in neoadjuvant or adjuvant setting and have recurrence at least 12 months following completion of immunotherapy are eligible after discussion with the principle investigator. * Pregnant or breast feeding individuals.
References
Publications (0)
Data not yet available
No reference posted for this study.