Not recruiting

Study of SGM-101 fluorescent imaging agent to guide surgery in patients with pancreatic cancer who received prior treatment

Fast replyInvestigationalNo placebo

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What is this trial about?

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

This study focuses on patients with pancreatic ductal adenocarcinoma, a type of pancreatic cancer that starts in the cells lining the ducts of the pancreas. The study will test a new imaging method using a medication called SGM-101, which is a special antibody solution that is given through intravenous infusion. This medication attaches to specific markers found on cancer cells and becomes visible under special light during surgery.

The purpose of this study is to determine if this new imaging technique can help surgeons better see the cancer and surrounding tissues during surgery. The medication SGM-101 is designed to make the cancer cells glow under near-infrared light, which could help doctors better identify where the cancer has spread and determine if it can be completely removed during surgery. This imaging approach is being tested in patients who have already received initial treatment before surgery.

During the study, participants will receive a single dose of SGM-101 before their scheduled surgery. The maximum amount given will be 10 milligrams. During the operation, special cameras will be used to detect the areas where the medication makes the cancer cells visible. The study will also collect blood and tissue samples to better understand how well this imaging method works.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial preparation
You will receive SGM-101, a specialized imaging medication that helps doctors see pancreatic tumors more clearly during surgery.
The medication will be given through an intravenous infusion (directly into your vein).
Step 2
Imaging procedure
During your scheduled surgery, doctors will use special near-infrared imaging systems to view the tumor and surrounding areas.
The imaging helps doctors see the primary pancreatic tumor, nearby lymph nodes, and possible spread of the disease.
The imaging system measures the difference between tumor tissue and normal tissue using a measurement called tumor-to-background ratio.
Step 3
Sample collection
During surgery, doctors will collect blood samples from different blood vessels.
Additional samples may include lymph fluid and tissue samples for laboratory analysis.
Step 4
Follow-up period
The study continues until April 30, 2025.
Additional blood samples may be collected during follow-up visits.
Laboratory tests will be performed on collected samples to study disease markers.

Who can join the trial?

8 criteria

Patient must provide signed informed consent before any study procedures begin
Patient must be over 18 years old
Patient must be able to communicate effectively in Dutch or English with the study team
Patient must be willing to follow all study requirements and restrictions
Patient must have pancreatic cancer that is either:
- Borderline resectable (tumor that might be surgically removable) or
- Locally advanced (tumor that has grown into nearby structures)
- Patient must have received neoadjuvant treatment (initial treatment given before main treatment) and be scheduled for surgical removal of the tumor
- Both men and women may participate in the study

Who cannot join the trial?

12 criteria

Age below 18 years or above 65 years
Presence of metastatic disease (cancer that has spread to other parts of the body)
Known allergies to antibodies or fluorescent dyes
Pregnancy or breastfeeding
Participation in another clinical trial within the past 30 days
Significant heart, kidney, or liver disease that could interfere with the study
History of other cancers in the past 5 years (except adequately treated non-melanoma skin cancer)
Inability to undergo surgery due to medical conditions
Mental conditions that prevent understanding of study requirements
Use of medications that could interfere with fluorescent imaging
Compromised immune system or active infections
Previous major abdominal surgery that could affect the study results

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Verified sites

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Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands

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Investigated drugs

SGM-101
is a specialized imaging agent that contains antibodies designed to bind to specific markers (carcinoembryonic antigen) found on pancreatic cancer cells. When injected into the body, this medication attaches to cancer cells and becomes fluorescent when exposed to near-infrared light during surgery. This helps surgeons better visualize the tumor and surrounding tissues during pancreatic cancer surgery, making it easier to determine the extent of the cancer and whether it can be completely removed.
Near-infrared (NIR) imaging systems
are special surgical equipment used in combination with SGM-101. These systems emit specific light that makes the SGM-101 glow, helping surgeons see the difference between cancerous and healthy tissue during the operation.

Chimeric Monoclonal Antibody Against Carcinoembryonic Antigen Conjugated To Fluorochrome Bm-104

What is already known about the treatment

SGM-101 - A fluorochrome-labeled monoclonal antibody designed for fluorescence-guided imaging during pancreatic cancer surgery, administered intravenously before the surgical procedure. This investigational imaging agent binds specifically to carcinoembryonic antigen (CEA) expressed by pancreatic cancer cells, making tumors visible under near-infrared light during surgery. The compound helps surgeons better visualize tumor boundaries and assess resectability of pancreatic ductal adenocarcinoma, particularly in patients who have undergone neoadjuvant treatment. SGM-101 belongs to the class of fluorescent contrast agents used in surgical oncology, with its primary mechanism of action based on antibody-antigen binding combined with fluorescence detection.

Investigated diseases

Pancreatic tumor - A growth that develops in the pancreas, an organ located behind the stomach. The tumor can start in any part of the pancreatic tissue and may be either benign (non-cancerous) or malignant (cancerous). The condition often develops gradually, affecting the normal function of the pancreas, which plays important roles in digestion and blood sugar regulation. As the tumor grows, it can affect surrounding tissues and organs in the abdomen. The condition may interfere with the pancreas's ability to produce digestive enzymes and hormones like insulin.