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Indocyanine Green Imaging for Stomach Cancer
Phase 2
Waitlist Available
Led By Alexandre Brind'Amour, MD
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial suggests that ICG is helpful in detecting peritoneal metastases in gastric adenocarcinoma patients during surgery, which can help improve patient outcomes.
Who is the study for?
This trial is for patients with confirmed gastric adenocarcinoma, without metastases seen on preoperative images, and a clinical stage of cT2 or higher. They must be fit enough for surgery (ECOG performance status 0 or 1). Those with lower stages of cancer, unfit for surgery, other types of stomach cancer, indocyanine allergy, or unconfirmed diagnosis are excluded.Check my eligibility
What is being tested?
The trial tests the use of Indocyanine Green (ICG) fluorescence imaging during surgery to detect peritoneal metastases in gastric adenocarcinoma patients. It aims to see if ICG can help find more cancer spread than usual methods during diagnostic laparoscopy.See study design
What are the potential side effects?
Potential side effects include allergic reactions to Indocyanine Green which may cause symptoms like rash, hives, difficulty breathing; however these are generally rare.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with additional lesions detected with ICG.
Number of patients with peritoneal metastases detected only with ICG.
Side effects data
From 2015 Phase 2 trial • 30 Patients • NCT0166275297%
Wound pain
40%
Nausea
13%
Ileus
10%
Vomiting
7%
Bloating
7%
Urinary tract infection
3%
Atrial fibrillation
3%
Dizziness
3%
Palpitations
3%
Paroxysmal atrial fibrillation
3%
Constipations
3%
Distended abdomen
3%
Epigastric pain
3%
Hiccough
3%
Febrile reaction
3%
Rigors
3%
Postoperative ileus
3%
Low haemoglobin
3%
Groin pain
3%
Tremor
3%
Confusion
3%
Urinary retention
3%
Atelectasis
3%
Low blood pressure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Indocyanine Green
Trial Design
1Treatment groups
Experimental Treatment
Group I: Gastric cancer with ICGExperimental Treatment1 Intervention
Patient to receive IV ICG during diagnostic laparoscopy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indocyanine green
2016
Completed Phase 4
~1720
Find a Location
Who is running the clinical trial?
Laval UniversityLead Sponsor
417 Previous Clinical Trials
172,261 Total Patients Enrolled
Ciusss de L'Est de l'Île de MontréalOTHER
70 Previous Clinical Trials
5,549 Total Patients Enrolled
Alexandre Brind'Amour, MDPrincipal InvestigatorLaval University
2 Previous Clinical Trials
70 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not fit for surgery due to my physical condition.My scans show cancer has spread to other parts of my body.My stomach cancer diagnosis is not confirmed.I have been diagnosed with stomach cancer.My cancer is at least stage cT2.My scans show no signs of cancer spread.My stomach cancer is not adenocarcinoma.I am fit for surgery.My cancer is in an early stage and small.
Research Study Groups:
This trial has the following groups:- Group 1: Gastric cancer with ICG
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being accepted for this research project?
"Affirmative. The information listed on clinicaltrials.gov demonstrates that this research is presently recruiting subjects. This study was first posted on December 15th 2022 and has been modified as recently as January 8th 2023, with the aim of enrolling 30 participants from two medical facilities."
Answered by AI
To what extent might Gastric cancer with ICG endanger patients?
"Due to the Phase 2 status of this trial, our evaluation at Power deemed Gastric cancer with ICG's safety level a medium-risk score of 2. There is some evidence of its security but no proof that it works yet."
Answered by AI
Are any new enrollees being admitted to this clinical trial at present?
"Affirmative. Clinicaltrials.gov data confirms that this medical study, which was originally posted on December 15th 2022, is actively recruiting participants. The investigation requires 30 patients to be recruited from two distinct clinical sites."
Answered by AI
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