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Study on Indocyanine Green with Extracellular Vesicles for Better Tumor Visualization in Patients Undergoing Surgery for Digestive System Cancers

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying certain types of solid tumors in the digestive system, such as colon, rectal, gastric, and pancreatic tumors, which can be treated with surgery. The trial will use a special formulation called OncoGreen, which combines a substance known as indocyanine green (ICG) with tiny particles from the patient's own blood called extracellular vesicles (EVs). This combination is used to help doctors see the tumors more clearly during surgery.

The purpose of the study is to test the safety and effectiveness of OncoGreen in helping surgeons better visualize tumor tissues and their edges during operations. The study will be conducted in two phases. In the first phase, the focus will be on ensuring that OncoGreen is safe and determining the best dose to use. In the second phase, the study will look at how well OncoGreen helps in seeing the tumors during surgery using a technique called fluorescence imaging, which makes the tumors glow under a special light.

Participants in the study will receive OncoGreen through an intravenous infusion, which means it will be delivered directly into their bloodstream. The study will monitor how well the tumors can be seen during surgery and check for any side effects. The goal is to improve the ability to see and remove tumors completely, which could lead to better outcomes for patients undergoing surgery for these types of cancers.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, consent is required to participate. This includes agreeing to the use of a special preparation called OncoGreen, which is made from your own blood components.
Eligibility is confirmed through various tests, including blood tests and heart monitoring, to ensure readiness for the study procedures.
Step 2
Plasmapheresis procedure
A procedure called plasmapheresis is performed. This involves collecting blood, separating certain components, and then returning the rest to the body.
The collected components are used to prepare the OncoGreen formulation, which will be used later in the study.
Step 3
Administration of OncoGreen
The OncoGreen formulation, which includes a substance called indocyanine green (ICG), is administered through an intravenous infusion. This means it is given directly into a vein.
The purpose of this is to help visualize tumor tissues during surgery using a special imaging technique.
Step 4
Surgical procedure
Surgery is performed to remove the tumor. During the procedure, the OncoGreen helps the surgical team see the tumor more clearly.
The goal is to ensure that as much of the tumor as possible is removed while preserving healthy tissue.
Step 5
Post-surgery follow-up
After surgery, follow-up visits are scheduled to monitor recovery and assess the effectiveness of the OncoGreen in helping to visualize the tumor.
These visits may include imaging tests and other assessments to ensure there are no complications and to evaluate the success of the tumor removal.

Who can join the trial?

7 criteria

Be able to provide written informed consent for the study, especially for the use of **EVs** (extracellular vesicles) loaded with **ICG** (a special dye) that are isolated from their own plasma through a **plasmapheresis** procedure (a process where blood is taken, processed to remove certain components, and then returned to the body) with subsequent re-infusion of the preparation called **OncoGreen**.
Be aged **18 years or older** at the time of signing the informed consent.
Have a **diagnosis of a solid tumor** of the digestive tract (such as colon-rectal tumors, gastric tumors, tumors of the liver, bile ducts, pancreas, and neuroendocrine areas) that requires surgical removal under general anesthesia.
Have a **performance status of 0-1** on the **ECOG performance scale** (a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities).
Meet the necessary technical and anesthetic requirements for cancer surgery aimed at curing the disease. This includes having routine blood, liver, kidney, and heart-lung function tests that are suitable for extensive cancer surgery following good clinical practice.
Be eligible for a **preoperative plasmapheresis procedure** as evaluated by a specialist in transfusion medicine. This includes a clinical reassessment, complete blood count, comprehensive biochemistry with electrolytes (such as calcium, sodium, and potassium), complete coagulation profile, and a recent **ECG** (a test that checks for problems with the electrical activity of the heart).
Have no active infection for **HIV**, **HCV**, **HBV**, and **Syphilis** at enrollment, proven by negative results from specific tests for these infections.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer that is not a solid tumor of the digestive system.
Patients whose tumors cannot be treated with surgery aimed at curing the disease.
Patients who are not able to undergo surgery for any reason.
Patients who have had previous treatment with the study drug, OncoGreen.
Patients with a known allergy to the study drug or any of its components.
Patients with severe medical conditions that could interfere with the study, such as uncontrolled heart disease or severe infections.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of drug or alcohol abuse that could interfere with the study.
Patients who are unable to give informed consent to participate in the study.

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Verified
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy

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Investigated drugs

Indocyanine Green (ICG)
is a special dye used in medical imaging. In this trial, it helps doctors see the edges of tumors more clearly during surgery. When injected into the body, it lights up under a special camera, making it easier for surgeons to identify and remove cancerous tissue.
Autologous Extracellular Vesicles (EVs)
are tiny particles taken from your own body. In this study, they are used to carry the indocyanine green dye directly to the tumor. This helps the dye reach the cancer cells more effectively, improving the visibility of the tumor during surgery. By using your own cells, the risk of rejection or adverse reactions is minimized.

Indocyanine Green

What is already known about the treatment

OncoGreen – OncoGreen is administered as a galenic formulation that combines indocyanine green (ICG) with autologous extracellular vesicles (EVs) and is used for in vivo diagnostics. It is currently being studied in a phase I/II clinical trial to assess its safety, tolerability, and effectiveness in improving the visualization of tumors during surgery. The main therapeutic indication for OncoGreen is to aid in the surgical treatment of solid tumors in the digestive system, such as colon, gastric, and pancreatic cancers, by enhancing the visibility of cancerous tissues and margins through fluorescence imaging. At the molecular level, OncoGreen works by using ICG, a dye that emits fluorescence, which is delivered to the tumor site via EVs, allowing surgeons to better see and remove cancerous tissues. This medication falls under the pharmacological classification of diagnostic agents used in surgical oncology.

Investigated diseases

Colorectal Cancer
Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, benign clumps of cells called polyps, which can develop into cancer over time. As the disease progresses, cancer cells can invade and destroy normal tissue nearby. The cancer may spread to other parts of the body, a process known as metastasis. Symptoms can include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary, with some cases remaining localized while others spread more extensively.
Gastric Cancer
Gastric cancer, also known as stomach cancer, originates in the stomach lining. It typically begins in the mucus-producing cells of the stomach and can grow slowly over many years. As it progresses, the cancer can invade deeper layers of the stomach wall and spread to nearby organs. Symptoms may include indigestion, stomach pain, nausea, and weight loss. The disease can spread to lymph nodes and other parts of the body. The progression and spread of gastric cancer can vary significantly among individuals.
Hepatobiliary Cancer
Hepatobiliary cancer refers to cancers that originate in the liver, bile ducts, or gallbladder. These cancers can develop from different types of cells within these organs. As the disease progresses, it can invade nearby tissues and spread to distant organs. Symptoms may include jaundice, abdominal pain, and weight loss. The progression can vary, with some tumors growing slowly and others spreading rapidly. The disease can affect liver function and overall health.
Pancreatic Cancer
Pancreatic cancer begins in the tissues of the pancreas, an organ that lies behind the lower part of the stomach. It often starts in the cells that line the ducts of the pancreas. As it progresses, the cancer can invade nearby organs and spread to distant parts of the body. Symptoms may include abdominal pain, weight loss, and jaundice. The disease can affect digestion and blood sugar regulation. The progression of pancreatic cancer can be aggressive, with a tendency to spread quickly.
Neuroendocrine Tumors
Neuroendocrine tumors are a diverse group of tumors that arise from neuroendocrine cells, which have traits similar to nerve cells and hormone-producing cells. These tumors can occur in various parts of the body, including the digestive system. They may grow slowly or rapidly, depending on their type and location. Symptoms can vary widely and may include flushing, diarrhea, and abdominal pain. As the disease progresses, it can spread to other parts of the body. The behavior and progression of neuroendocrine tumors can be unpredictable.