Clinical trial · Interventional
Gastric In Vivo Study
Endoscopic Multispectral Imaging for the Early Detection of Gastric Neoplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institution
Summary
Brief summary (as posted)
The overall objective of this pilot study is to determine whether multispectral imaging increases the diagnostic accuracy of the current standard of high-definition white-light endoscopy for the detection of gastric neoplasia (high grade dysplasia or cancer). As part of an NCI-funded RO1, the investigators goal is to develop a multispectral endoscopic platform that can be used to survey a large surface area and, potentially, serve as a "red flag" for microendoscopic imaging of small areas. In prior ex vivo evaluations of surgical and endoscopic specimens, the investigators have identified the optical settings and illumination wavelengths that are complementary to white-light imaging and enhance superficial mucosal and vascular changes associated with neoplasia. Based on this initial testing, vital-dye enhanced fluorescence imaging (VFI) and imaging with High Resolution Microendoscope (HRME) have been identified as modalities that may be complementary to white-light imaging. The goal of this pilot study is to preliminarily determine the accuracy of these modalities during the endoscopic surveillance and detection of gastric neoplasia.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imaging with High Resolution Microendoscope | Procedure | — | UNRESOLVED |
| Proflavine Hemisulphate salt | Drug | — | UNRESOLVED |
| White-light examination | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surveillance Endoscopy
- description
- White light examination, vital-dye enhanced fluorescence examination (VFI), High Resolution Microendoscope (HRME)
- interventionNames
- Drug: Proflavine Hemisulphate salt
- Procedure: White-light examination
- Procedure: Imaging with High Resolution Microendoscope
Primary outcomes (1)
- measure
- Gastric neoplasia presence
- timeFrame
- Day 1
- description
- Comparison of the efficiency of widefield imaging modality or combination of modalities (WLE, WLE+VFI/HRME for the highest accuracy on the detection of gastric neoplasia
Secondary outcomes (2)
- measure
- Sensitivity for the detection of neoplasia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with high grade dysplasia in the stomach and known or suspected cancer of the stomach undergoing endoscopic surveillance * at least 18 years of age Exclusion Criteria: * subjects who report an allergy to Proflavine
References
Publications (0)
Data not yet available