NIR-Fluorescence Guided Surgical Resection of Neoadjuvant Treated Localized Pancreatic Cancer Using SGM-101

NCT05984810 | Recruiting Phase 2 DMC

• 3 other identifiers: P23.0182023-000026-28NL82221.058.23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic carcinoma has a dismal prognosis at time of diagnosis, due to late onset of clinical symptoms, patients present with advance disease. Complete surgical resection is the only potential curative treatment, however only a small percentage is eligible for upfront total surgical resection due to extension into anatomical related important vascular structures. Neoadjuvant chemo(radio)therapy has become the standard treatment modality for non-primary resectable disease (borderline resectable and locally advanced pancreatic cancer (LAPC)), where subsequent downstaging can make identification of the primary tumor more challenging during surgery. Near-infrared (NIR) fluorescence imaging can aid surgeons by providing real-time visualization of tumors, suspect lymph nodes and vital structures during surgery. Additional intra-operative feedback could possibly reduce the frequency of positive resection margins and increase complete removal of locally spread tumor and involved lymph nodes and could thereby improve patient outcomes as well as overall survival. SGM-101 is a targeted NIR-fluorophore, with specific binding capacity for Carcino Embryonic Antigen (CEA) which is overexpressed on tumor cells in the gastro-intestinal tract, including pancreatic cancer.

Conditions

Pancreas Adenocarcinoma

Keywords

Fluorescence Guided Surgery; Pancreatic Ductal Adenocarcinoma; Neoadjuvant therapy; Near-Infrared (NIR) Fluorescence imaging; CEA

Outcome Measures

Primary Outcomes (1)

• Intra-operative visualization of neoadjuvant treated pancreatic tumors using Near-infrared fluorescence imaging,

  The ability to visualize the primary pancreatic tumor, the local tumor extent and resectability status, with adjacent lymph nodes. As well as potential distant metastatic lesions, using SGM-101 and dedicated NIR-imaging systems. Visualization is measured using the tumor-to-background ratio (TBR) in ex-vivo settings. A tumor-to-background ratio (TBR) of at least ≥1.5 provides sufficient contrast for adequate visualization/delineation and will therefore be used as cut-off value.

  Surgery -

Secondary Outcomes (2)

• Concordance between fluorescent signal and tumor status of resected tissue

  Through study completion, an average of 3 months

• Concordance between fluorescent signal and tumor status of resection margins.

  Through study completion, an average of 3 months

Study Arms (1)

10mg, administered 3-5 days before surgery

EXPERIMENTAL

Drug: SGM-101 Intravenous single injection of the targeted NIR fluorophore SGM-101. This targeted 700nm fluorophore developed by SurgiMab S.A.S., Montpellier, France. Device: Intraoperative near-infrared fluorescence imaging Intraoperative imaging will be performed with the following CE-marked near-infrared (NIR) fluorescence imaging system: Quest Spectrum imaging platform (v2/3.0). With a NIR-imaging system a potential fluorescent signal of the tumor can be evaluated. Furthermore, the Quest Spectrum platform will also be used for evaluation of ex-vivo fluorescence of resected tissue on the back table (Back table imaging) and pathology department (ex-vivo imaging), which shall be performed during and after every procedure.

Procedure: Fluorescence-guided surgery using CEA-targeted fluorophore SGM-101

Interventions

Fluorescence-guided surgery using CEA-targeted fluorophore SGM-101 PROCEDURE

Fluorescence-guided surgery using CEA-targeted fluorophore SGM-101

10mg, administered 3-5 days before surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to any study-mandated procedure;
• Patients aged over 18 years old;
• Has the ability to communicate well with the Investigator in the Dutch/English language and willing to comply with the study restrictions.
• Neoadjuvant treated (borderline) resectable or locally advanced pancreatic cancer scheduled for a surgical resection
• Signed informed consent prior to any study-mandated procedure;
• Patients aged over 18 years old;
• Has the ability to communicate well with the Investigator in the Dutch/English language.

You may not qualify if:

• Part A: To be eligible for conclusion in this study, patients must meet none of the following criteria:
• History of clinically significant anaphylactic reactions;
• Previous administration of SGM-101;
• Pregnant women, or women giving breast feeding;
• Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
• Part B: To be eligible for conclusion in this study, healthy volunteers must meet none of the following criteria:
• Previous administration of SGM-101;
• Pregnant women, or women giving breast feeding;
• Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Dutch Cancer Society: collaborator
• Surgimab: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, 2300RC, Netherlands

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical oncologist, Head of Vahrmeijer Research Lab

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 9, 2023
• Study Start: March 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)