Gastric CancerPhase 1NCT02207959
Gastric In Vivo Study
A Phase 1 study testing Proflavine Hemisulphate salt, White-light examination and Imaging with High Resolution Microendoscope in people with Gastric Cancer, run by Susana Gonzalez at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Proflavine Hemisulphate salt, White-light examination and Imaging with High Resolution Microendoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- subjects who report an allergy to Proflavine
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Endoscopic Multispectral Imaging for the Early Detection of Gastric Neoplasia
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.
Read the detailed description
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:
- White Light Examination: Examination will initially be performed in the standard white-light endoscopic mode as is routinely done. Abnormal gastric mucosa areas and nodularities will be recorded. Any "Suspicious" areas (visible abnormalities, etc.) will be photographed and the location recorded (distance from incisors and endoscopic quadrant, eq. 34 cm; greater curvature, lesser curvature, etc).
- Vital-Dye Enhanced Fluorescence Examination: Following this, the stomach will be sprayed with 1-10 ml of 0.01% proflavine using a standard endoscopic spray-catheter. Using the fluorescent imaging, the location of any VFI-"Suspicious' areas will be recorded. Additionally, VFI examination of any suspicious areas seen on WLE will be performed. The endoscopist will label the surface-appearance of each WLE abnormal area based on its VFI appearance. Thus, each area will be labeled as: "Not Suspicious," or "Suspicious for Neoplasia."
- HRME examination: WLE and VFI suspicious appearing areas will be further imaged with HRME. HRME will be inserted through the biopsy channel of the endoscope, gently placed against the mucosa, and images of suspicious areas will be obtained. The endoscopist will label the surface-appearance of each WLE abnormal area and VFI abnormal area, based on the HRME appearance. Thus, each area will be labeled as: "Not Suspicious," or "Suspicious for Neoplasia."
- Biopsy Protocol: Biopsies will be obtained of any area suspicious on any of the imaging modalities (WLE, VFI or HRME). Additionally, two 'control' areas (normal on imaging) will also be biopsied. Lastly, routine, biopsies will be performed per clinical care to determine areas of intestinal metaplasia and H pylori infection as per routine standard of care.
- Pathologic Interpretation: All samples will be evaluated by a single expert gastrointestinal pathologist who will be blinded to the endoscopic findings
- Conditions
- Gastric Cancer
- Being tested
- Proflavine Hemisulphate salt, White-light examination, Imaging with High Resolution Microendoscope
- Keywords
- Gastric cancer, Neoplasia, Endoscopic imaging, In vivo imaging
- Medical subject headings
- Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proflavine Hemisulphate saltDrug
Also called Vital-dye enhanced fluorescence imaging, VFI
The stomach will be sprayed with 1-10 ml of 0.01% proflavine using a standard endoscopic spray-catheter.
White-light examinationProcedure or surgery
Also called White-light endoscopic examination
standard white light examination
Imaging with High Resolution MicroendoscopeProcedure or surgery
Also called HRME, VFI/HRME
HRME will be inserted through the biopsy channel of the endoscope, gently placed against the mucosa, and images of suspicious areas will be obtained.
| Study group | Role | What they receive |
|---|---|---|
| Surveillance Endoscopy | Experimental | White light examination, vital-dye enhanced fluorescence examination (VFI), High Resolution Microendoscope (HRME) Receives: Drug: Proflavine Hemisulphate salt; Procedure: White-light examination; Procedure: Imaging with High Resolution Microendoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (2)
Sensitivity for the detection of neoplasia
the potential errors in estimation of sensitivity (true positive rate)
Measured: Day 1
Specificity for the detection of neoplasia
the potential errors in estimation of specificity (true negative rate)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susana Gonzalez
- Sponsor type
- University, hospital or other
- Collaborators
- William Marsh Rice University
- Responsible party
- Sponsor-investigator, Susana Gonzalez, Icahn School of Medicine at Mount Sinai
- Investigators
- Susana Gonzalez, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207959
- Sponsor's protocol ID
- GCO 09-0696B
- Status last verified
- Apr 2017
- First submitted
- 31 Jul 2014
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Multispectral Imaging for the Early Detection of Gastric Neoplasia
- ClinicalTrials.gov ID
- NCT02207959
- Acronym / sponsor ID
- GCO 09-0696B
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Neoplasia, Endoscopic imaging, In vivo imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Susana GonzalezUniversity, hospital or other
- Collaborators
- William Marsh Rice University
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- White Light Examination: Examination will initially be performed in the standard white-light endoscopic mode as is routinely done. Abnormal gastric mucosa areas and nodularities will be recorded. Any "Suspicious" areas (visible abnormalities, etc.) will be photographed and the location recorded (distance from incisors and endoscopic quadrant, eq. 34 cm; greater curvature, lesser curvature, etc).
- Vital-Dye Enhanced Fluorescence Examination: Following this, the stomach will be sprayed with 1-10 ml of 0.01% proflavine using a standard endoscopic spray-catheter. Using the fluorescent imaging, the location of any VFI-"Suspicious' areas will be recorded. Additionally, VFI examination of any suspicious areas seen on WLE will be performed. The endoscopist will label the surface-appearance of each WLE abnormal area based on its VFI appearance. Thus, each area will be labeled as: "Not Suspicious," or "Suspicious for Neoplasia."
- HRME examination: WLE and VFI suspicious appearing areas will be further imaged with HRME. HRME will be inserted through the biopsy channel of the endoscope, gently placed against the mucosa, and images of suspicious areas will be obtained. The endoscopist will label the surface-appearance of each WLE abnormal area and VFI abnormal area, based on the HRME appearance. Thus, each area will be labeled as: "Not Suspicious," or "Suspicious for Neoplasia."
- Biopsy Protocol: Biopsies will be obtained of any area suspicious on any of the imaging modalities (WLE, VFI or HRME). Additionally, two 'control' areas (normal on imaging) will also be biopsied. Lastly, routine, biopsies will be performed per clinical care to determine areas of intestinal metaplasia and H pylori infection as per routine standard of care.
- Pathologic Interpretation: All samples will be evaluated by a single expert gastrointestinal pathologist who will be blinded to the endoscopic findings
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surveillance Endoscopy | Experimental | Drug: Proflavine Hemisulphate salt, Procedure: White-light examination, Procedure: Imaging with High Resolution MicroendoscopeWhite light examination, vital-dye enhanced fluorescence examination (VFI), High Resolution Microendoscope (HRME) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- subjects who report an allergy to Proflavine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proflavine Hemisulphate saltAlso: Vital-dye enhanced fluorescence imaging, VFIThe stomach will be sprayed with 1-10 ml of 0.01% proflavine using a standard endoscopic spray-catheter. | Drug | Surveillance Endoscopy |
| White-light examinationAlso: White-light endoscopic examinationstandard white light examination | Procedure or surgery | Surveillance Endoscopy |
| Imaging with High Resolution MicroendoscopeAlso: HRME, VFI/HRMEHRME will be inserted through the biopsy channel of the endoscope, gently placed against the mucosa, and images of suspicious areas will be obtained. | Procedure or surgery | Surveillance Endoscopy |
Primary outcome
Gastric neoplasia presence
Time frame: Day 1
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
2 secondary outcomes
Sensitivity for the detection of neoplasia
Time frame: Day 1
Specificity for the detection of neoplasia
Time frame: Day 1
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
Related trials for Gastric Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
Active, not recruitingPhase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
RecruitingPhase 4
Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
Gastrointestinal Cancer, Gastric Cancer
RecruitingObservational study
Development and Utilization of an Integrated Clinical Genomic Database
Gastric Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana Gonzalez, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Proflavine Hemisulphate salt, White-light examination and Imaging with High Resolution Microendoscope in people with Gastric Cancer, run by Susana Gonzalez at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric neoplasia presence (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.