Study on the detection of cancer during surgery for rectal cancer or pancreatic cancer with the fluorescent agent SGM-101 '
Recruiting
- Conditions
- rectal cancerpancreatic cancer
- Registration Number
- NL-OMON21037
- Lead Sponsor
- eiden University Medical Center (LUMC) and Centre for Human Drug Research (CHDR), Leiden, the Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Patients aged over 18 years old;
2. Patient should be scheduled and eligible for surgery because of a clinical diagnosis of cancer of the
rectum or cancer of the pancreas;
Exclusion Criteria
1. Anticancer therapy (e.g. chemotherapy, radiotherapy(except routine pre-operative radiotherapy for
rectal cancer), targeted therapy, concomitant systemic immune therapy, or any experimental therapy)
within 4 weeks before inclusion;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability (primary endpoint)<br /><br>Tolerability/safety will be assessed using routine clinical measures such treatment-emergent adverse events,<br>blood pressure, heart rate, temperature, peripheral oxygen saturation, respiratory rate, skin examination, and<br>routine laboratory assessments. DLT is defined as grade ≥ 3 NCI-CTCAE V4.03 toxicity related to SGM-101 treatment between the day of injection and 10 days after surgery. The MTD is defined as the dose at which at least two out of two-to-six patients experience one DLT in the observation sequence defined as the interval between infusion of SGM-101 and 10 days after the surgery.
- Secondary Outcome Measures
Name Time Method Performance (secondary endpoint)<br /><br>Performance of SGM-101 will be defined by tumor to background ratio (TBR) for fluorescence, and the<br>concordance between the intraoperative fluorescence assessment of suspected lesions and their<br>histopathology. In addition after resection, margins will be assessed using fluorescence imaging to detect<br>potential irradical resection.<br /><br>Pharmacokinetics (secondary endpoint)<br /><br>Cmax, T½, AUC, Tmax, Clearance. In addition, the relationship between pharmacokinetics and performance<br>will be assessed.