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

2 1 1

What is this study about?

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.

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).

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.

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.

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Lbpcy Umbjrqpdtwto Mnwqucr Cflqfsj (lcwjy	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	17.09.2023

Trial locations

Investigated drugs:

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

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.

Investigated diseases:

Ductal adenocarcinoma of pancreas

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.

Trial ID:

2023-510481-27-00

NCT ID:

NCT05984810

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?