Study for Intra-operative Imaging of Cancer using a New Fluorescent Agent

Recruiting

• Conditions: Ovarian Cancer; Endometrial Cancer; Endometrium carcinoom; Renal Cell CancerOvarium carcinoom; Niercel carcinoom

• Registration Number: NL-OMON20365
• Lead Sponsor: eiden University Medical Center and Centre for Human Drug Research, Leiden, the Netherlands

Brief Summary

n/a

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Inclusion criteria ovarian cancer:

1. Known or high clinical suspicion of primary ovarian cancer planned for either primary debulking surgery or interval debulking surgery by laparotomy (18 patients)

Exclusion Criteria

1. Any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient

2. History of anaphylactic reactions or severe allergies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tolerability / safety endpoints<br /><br>Treatment-emergent adverse events (TEAEs) using MedDRA from the time of administration throughout the study period, and changes in serum biochemistry, hematology, vital signs, ECG, injection site status, and physical examination findings.

Secondary Outcome Measures

Name	Time	Method
Efficacy endpoints<br /><br>1. TBR, defined as fluorescent signal of tumor tissue compared to fluorescence signal of tissue surrounding the tumor, at different doses;<br /><br>2. Concordance between the pathology results with respect to the presence of cancer and the imaging assessment;<br /><br>3. Number and location of FR-a+, cancer+ tumor lesions and resection margins identified under usual visual/tactile conditions, under both usual visual/tactile conditions and fluorescent light, and under fluorescent light only<br /><br>4. Surgeons’ opinion regarding utility of IV OTL-038 injection and imaging system<br><br /><br /><br>Pharmacokinetic endpoints<br /><br>Cmax, T½, AUC, Tmax, Clearance