Clinical trial · Interventional
Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer
- 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 investigates fluorine-18-AlphaVBeta6-BP (\[18F\]-αvβ6-BP) as a Positron Emission (PET) imaging agent in Non-Small Cell Lung Cancer (NSCLC) patients with brain metastases. Investigators hypothesize that \[18F\]-αvβ6-BP PET/Computed Tomography (CT) is a sensitive tool for disease assessment in patients with metastatic NSCLC, including those with brain metastases.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer Metastatic | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]-αvβ6-BP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental [18F]-αvβ6-BP
- description
- Patients receive \[18F\]-αvβ6-BP BP IV and then undergo a PET/CT scan over 30 minutes 60 minutes post-injection.
- interventionNames
- Drug: [18F]-αvβ6-BP
Primary outcomes (1)
- measure
- [18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry
- timeFrame
- Up to six months
- description
- Standard uptake value (SUV) values from \[18F\]-αvβ6-BP PET/CT will be compared to immunohistochemistry (IHC) αvβ6 staining of archival tissue to assess the sensitivity of \[18F\]-αvβ6-BP PET/CT to detect αvβ6 positive metastasis in NSCLC
Secondary outcomes (3)
- measure
- Comparison of standard-of-care MRI and [18F]-αvβ6-BP PET/CT imaging
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men and women age \>18 yrs 2. Biopsy proven NSCLC with brain metastases (treated or untreated) 3. Life-expectancy of ≥3 months in the opinion of the treating physician 4. Available archival tumor tissue (excisional, core, or fine needle aspiration (FNA) is acceptable). Tissue from a metastatic site is preferred when available. 5. Able to tolerate all study procedures, including remain motionless for up to 30-60 minutes per scan 6. Ability to understand and willingness to sign a written informed consent document. 7. Planned to undergo additional cancer-directed therapy followed by standard-of-care re-staging imaging 8. \[18F\]-FDG PET/CT within 21 days of enrollment 9. MRI brain within 21 days of enrollment 10. Eastern Cooperative Oncology Group Performance Status ≤ 2 11. Glomerular filtration rate (GFR) ≥ 60 Exclusion Criteria: 1. Pregnant or lactating women 2. Prisoners 3. Concurrent malignancy of a different histology that could confound imaging interpretation 4. Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)
References
Publications (0)
Data not yet available