FLUOPANC II: A performance study of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for fluorescence-guided imaging to determine local extent and resectability during surgical resection of pancreatic ductal adenocarcinoma after neoadjuvant treatment.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Academisch Ziekenhuis Leiden

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04], Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]

Trial duration

11 Dec 2023 → 23 Mar 2026

Decision date (initial)

2024-10-01

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Subsidy A.L. Vahrmeijer

External identifiers

EU CT number

2023-510481-27-00

EudraCT number

2023-000026-28

ClinicalTrials.gov

NCT05984810

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Diagnosis, Efficacy

The ability to accurately 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 in-vivo and ex-vivo setting. A tumor-tobackground ratio (TBR) of at least ≥1.5 provides sufficient contrast for adequate visualization / delineation and will therefore be used as cut-off value.

Secondary objectives 4

1. Concordance to pathology results with respect to the presence of cancer and the imaging assessment, based on fluorescent signal and the tumor status (incl. degree of CEAexpression) of biopsied or resected tissue. Measured by calculation of the sensitivity for accurate (tumor+) signal.
2. Tumor positive margins detected based on solely NIR fluorescence imaging using SGM-101, referenced to histopathology.
3. Number of tumor-positive lymph nodes and distant metastatic disease detected by NIR fluorescence imaging using SGM-101, referenced to histopathology.
4. Number and grade of treatment-emergent (serious) adverse events ((S)AEs).

Conditions and MedDRA coding

Pancreatic tumor

Regulatory references

Scientific advice from competent authorities

METC Leiden Den Haag Delft, Central Committee On Research Involving Human Subjects

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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

Exclusion criteria 4

1. History of clinically significant anaphylactic reactions
2. Previous administration of SGM-101
3. Pregnant women, or women giving breast feeding
4. Any condition that the investigator considers to be potentially jeopardizing the patient’s wellbeing or the study objectives

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The ability to visualize the primary pancreatic tumor, the local tumor extent and resectability status, with adjacent lymph nodes and to visualize also potential distant metastatic lesions, using SGM-101 and dedicated NIR-imaging systems.

Secondary endpoints 4

1. Concordance to pathology results with respect to the presence of cancer and the imaging assessment, based on fluorescent signal and the tumor status (incl. degree of CEA-expression) of biopsied or resected tissue. Measured by calculation of the sensitivity for accurate (tumor+) signal.
2. Detection and quantification of circulating TiMas in samples of (porto) venous blood, lymph fluid and the lymphatic system obtained during surgery and follow-up
3. Detection, quantification and characterization of tdEVs in portal-vein blood samples through flow cytometry, glycomics and cryo-electron microscopy. The data obtained will be correlated with clinical parameters
4. Detection, quantification and characterization of tdEVs in peripheral blood samples through flow cytometry, glycomics and cryo-electron microscopy. The data obtained will be compared to data from portal-vein blood samples and correlated with clinical parameters

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Academisch Ziekenhuis Leiden

Sponsor organisation

Academisch Ziekenhuis Leiden

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

Clinical Research Center, dept. of Surgery

Public contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

Clinical Research Center, dept. of Surgery

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications