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

Phase 2

Recruiting

• Conditions: pancreatic cancer; pancreatic carcinoma; 10017990; 10017991

• Registration Number: NL-OMON56065
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

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 non-primary resectable (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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified