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| Name | Class |
|---|---|
| William Marsh Rice University | OTHER |
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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.
Consent will be obtained the day of the subject's scheduled endoscopy in a clinical room or at a routine office visit prior to the endoscopy. The study investigator will explain the study including the reasons why subject may be eligible, risks, and benefits. The subject will be given a chance to address any questions or concerns they may have.
If the patient agrees to participate in this study all of the procedures listed below will be performed the day of the scheduled endoscopy exam. The procedures listed are part of the routine standard of care for an endoscopy exam, except for the images that are being taken and the additional 2-6 biopsies taken from any abnormal areas that are seen with the new imaging technique. The use of the imaging technique described in this research study will not change the standard of care procedures.
The endoscopic procedure is outlined below:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surveillance Endoscopy | Experimental | White light examination, vital-dye enhanced fluorescence examination (VFI), High Resolution Microendoscope (HRME) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proflavine Hemisulphate salt | Drug | The stomach will be sprayed with 1-10 ml of 0.01% proflavine using a standard endoscopic spray-catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric neoplasia presence | 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 | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity for the detection of neoplasia | the potential errors in estimation of sensitivity (true positive rate) | Day 1 |
| Specificity for the detection of neoplasia | the potential errors in estimation of specificity (true negative rate) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susana Gonzalez, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
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| White-light examination | Procedure | standard white light examination |
|
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| Imaging with High Resolution Microendoscope | Procedure | HRME will be inserted through the biopsy channel of the endoscope, gently placed against the mucosa, and images of suspicious areas will be obtained. |
|
|
| Day 1 |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |