Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome
Condition: Gastric Cancer; Gastric Neoplasms
MeSH terms: Stomach Neoplasms
Intervention: Endoscope+Cellvizio(R) 100 microscope
Intervention description: Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diagnostic; Diagnosis; EGD; Examination of Stomach

Summary:

      Background:

      People with hereditary gastric cancer syndrome are at increased risk of getting cancer in
      their stomach. These people should have regular endoscopies and biopsies to check for cancer
      if they are choosing to keep their stomach. Researchers want to see if they can improve the
      detection of cancer by endoscopy. Improved endoscopies could better detect early signs of
      cancer in people with this syndrome.

      Objective:

      To see if a small microscope attached to an endoscope to inspect the stomach lining is better
      than regular endoscopy to find the first signs of cancer in the stomach.

      Eligibility:

      People ages 18 and older who have a personal or family history of a hereditary gastric cancer
      syndrome or have a mutation that is known to lead to gastric cancer

      Design:

      Participants will be screened over the phone or in person with:

        -  Personal and family medical history

        -  Review of their medical records

      Participants will have a physical exam. Then they will be put under general anesthesia. They
      will have an endoscopy. A lighted tube will be inserted into the mouth and go down to the
      stomach. First, the standard device will be used. Then participants will be injected with
      fluorescein. This is a contrast agent. Then the microscope will be added to the tube and the
      endoscopic evaluation of the stomach will be repeated. During the procedure, biopsies will be
      taken from different areas of the stomach. Participants will be observed for a few hours
      after the procedure.

      About 14 days after the endoscopy, participants will be asked to return to the clinic for a
      follow-up visit. This visit can also be conducted over the phone.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Patients with Cadherin-1 (CDH1) germline mutation known to be pathogenic or likely
             pathogenic, which may also be classified as "significant" or "likely significant"
             (patients with variants of "uncertain significance " are excluded)

        or

        -Patients with Catenin Alpha 1 (CTNNA1) and partner and localizer of breast cancer 2
        (BRCA2) (PALB2) germline mutations suspected to be, or reported to be, associated with
        hereditary diffuse gastric cancer (HDGC) syndrome.

        or

          -  In the absence of a germline CDH1 mutation, patients must meet clinical criteria for
             genetic testing due to a history suggestive of Hereditary Diffuse Gastric Cancer
             (HDGC) syndrome

          -  Age greater than or equal to 18 years.

          -  Physiologically able to undergo upper endoscopy.

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  Pregnant women are eligible during second trimester of pregnancy if clinically
             indicated for evaluation of cancer.

        EXCLUSION CRITERIA:

          -  Current use of therapeutic anticoagulation medication

          -  Known bleeding disorder or thrombocytopenia.

          -  Unstable angina or recent (within 3 months) myocardial infarction

          -  Any clinical contraindication to general anesthesia