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

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 - FLUOPANC-II

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56065

Enrollment

Registered

2023-02-21

Start date

2024-02-29

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer pancreatic carcinoma

Interventions

Intervention: single intravenous administration of SGM-101 3-5 days before surgery. Intra-operative in-vivo assessment of NIR fluorescence of tumour, lymph nodes, possible distant metastases and ana

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patienten (Part A): 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 (localized) pancreatic cancer and scheduled for a surgical resection Deel B - Gezonde vrijwilligers 1. Ondertekende geïnformeerde toestemming voorafgaand aan elke door het onderzoek voorgeschreven procedure; 2. Patiënten ouder dan 18 jaar; 3. Goed kunnen communiceren met de onderzoeker in de Nederlandse/Engelse taal.

Exclusion criteria

Exclusion criteria: Patienten (Part A): 1. History of clinically significant anaphylactic reactions; 2. Previous use 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 well-being or the study objectives. Part B - Healthy volunteers 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.

Design outcomes

Primary

Measure	Time frame
Determination of the performance of SGM-101 as a fluorescent tracer for NIR-Fluorescence-guidance (FLI) during surgical pancreatic resections after neoadjuvant therapy for assessment of (local) tumor extent and delineation of the primary tumor, local lymph nodes and potential distant metastatic disease Outcome: The ability to accurately 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. Visualization is measured using the tumor-to-background ratio (TBR) in in-vivo and ex-vivo setting. 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.	—

Measure

Time frame

Determination of the performance of SGM-101 as a fluorescent tracer for NIR-Fluorescence-guidance (FLI) during surgical pancreatic resections after neoadjuvant therapy for assessment of (local) tumor extent and delineation of the primary tumor, local lymph nodes and potential distant metastatic disease Outcome: The ability to accurately 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. Visualization is measured using the tumor-to-background ratio (TBR) in in-vivo and ex-vivo setting. 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.

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Secondary

Measure	Time frame
- Concordance between fluorescent signal and tumor status of resected tissue, as well as concordance between fluorescent signal and tumor status of resection margins. Endpoint: 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. - To assess intraoperative changes in surgical plan based on FLI (e.g. extension, reduction of resection margins, or additional resection) and correlated the accuracy to the histopathological ground truth. Endpoint: Record number (and %) of patients in which an intraoperative change of surgical plan was made based on FLI and correlate these changes to the histological ground truth.	—

Measure

Time frame

- Concordance between fluorescent signal and tumor status of resected tissue, as well as concordance between fluorescent signal and tumor status of resection margins. Endpoint: 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. - To assess intraoperative changes in surgical plan based on FLI (e.g. extension, reduction of resection margins, or additional resection) and correlated the accuracy to the histopathological ground truth. Endpoint: Record number (and %) of patients in which an intraoperative change of surgical plan was made based on FLI and correlate these changes to the histological ground truth.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)