Phase I – EAGLE-study

Title: Molecular Fluorescence Endoscopy for the Detection of (pre)Malignant Lesions in Barrett’s Esophagus using a Fluorescent Tracer EMI-137 Targeting c-Met: a Single-center Feasibility and Safety Study.

Study design: The current study is a non-randomized, non-blinded, prospective, single-center feasibility study. Patients with a suspicion of at least low-grade dysplasia (LGD), that are planned to undergo a second diagnostic and/or therapeutic endoscopy will receive an intravenous (IV) injection of the c-Met targeted fluorescent tracer EMI-137 approximately 2.5 hours before the start of the endoscopic procedure. The endoscopy and study procedure will be clustered in one session: first routine inspection with a high-definition white-light (HD WL) endoscope, followed by fluorescence inspection with a probe-based F2 multispectral camera system (SurgVision BV). Quantification of fluorescence signals will be performed in vivo and ex vivo with multi-diameter single fiber fluorescence single fiber spectroscopy (MDSFR-SFF) measurements of fluorescent lesions. Biopsies will be taken in order to correlate fluorescence signals to histology.

Objectives: The main objectives of this pilot study are to determine the safety and feasibility of molecular fluorescence endoscopy using the fluorescent tracer EMI-137 in order to detect dysplasia and/or malignant lesions in patients with BE.

Study population: A total of 20 patients to 25 patients with a suspicion of at least low grade dysplasia (LGD) in BE that are scheduled to undergo a second diagnostic or therapeutic endoscopy will be included.

Status: Completed

Read more

Phase I – ORCA-study

Title: Fluorescence Molecular Endoscopy of Locally Advanced Esophageal Carcinoma using Bevacizumab-800CW to Evaluate Dose Response After Neoadjuvant Chemoradiotherapy: a single-center feasibility study.

Study design: The current study is a non-randomized, non-blinded, prospective, single center study in patients with locally advanced esophageal carcinoma. For this study, patients will undergo generally two endoscopic procedures: (1) before the start of nCRT (on an opt-out basis) as part of the normal clinical workflow and (2) after nCRT but before surgery. Both endoscopies start with high-definition white-light endoscopy, followed by fluorescence inspection with a probe-based F2 multispectral camera system (SurgVision BV). Quantification of fluorescence signals in vivoand ex vivois performed with multidiameter single fiber fluorescence single fiber (MDSFR-SFF) spectroscopy. Biopsies will be taken in order to correlate fluorescence signals to histology. Last, the fresh surgical specimen will be imaged and analyzed ex vivo.

Objectives: The main objectives of this pilot study are to determine the safety and feasibility of fluorescence molecular endoscopy using the fluorescent tracer bevacizumab-800CW for identification of pathological complete response after neoadjuvant chemoradiotherapy in patients with a locally advanced esophageal carcinoma.

Study population: A total of 30 patients with locally advanced esophageal carcinoma (cT1b-4a N0-3 M0), both adenocarcinoma and squamous cell carcinoma, scheduled to receive nCRT followed by esophagectomy will be included in this study.

Status: Recruiting

Read more

Phase I – ESCEND-study

Title: Detection of early esophageal cancer by near-infrared fluorescence molecular endoscopy.

Study design: To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in Barrett’s Esophagus (BE), there is a need for better endoscopic visualization and the ability for targeted biopsies. Optical molecular imaging of neoplasia associated biomarkers could form a promising technique to accommodate this need. The phase I feasibility trial (VICE study: ABR NL NL45554.042.14), showed that synchronal use of VEGFA-guided near-infrared fluorescence molecular endoscopy (NIR-FME) and high-definition white light endoscopy (HD-WLE), following topical or systemic tracer administration, could be practiced to recognize dysplastic and early EAC lesions in patients with BE. Furthermore, early lesion detection was improved by ~33% using the tropical tracer approach compared with HD-WL/NBI endoscopy. We aim to statistically confirm previous pilot (Phase I) clinical data showing that the combination of HD-WLE and FME  using labelled bevacizumab improves early EC detection over the current clinical standard.

Objectives: Main objective: determine the percentage of patients in which NIR-FME reveals additional neoplastic lesions compared to HD-WLE.

Study population: A total of 60 patients patients with a suspicion of at least low grade dysplasia (LGD) in BE that are scheduled to undergo a second diagnostic or therapeutic endoscopy will be included.

Status: Recruiting

Read more

Phase I – VICE study

Title: A Pilot Intervention Study for the Use of VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions

Status: Completed

Read more

Phase I – Fluo-FAP study

Title: Visualization of a VEGF-targeted Near-Infrared Fluorescent Tracer in Patients With Familial Adenomatous Polyposis During Fluorescence Endoscopy A Single Center Pilot Intervention Study

Status: Completed

Publication: Here

Read more

Phase I – VICE study

Title: A Pilot Intervention Study for the Use of VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions

Status: Completed

Publication: Here

Read more

Phase I – Rapido-TRACT study

Title: Visualization of a VEGF-targeted Optical Fluorescent Imaging Tracer in Rectal Cancer During Flexible NIR Fluorescence Endoscopy

Status: Recruiting

Read more

Phase I – COUGAR-study

 Title: Cholangiocarcinoma detection using an intraoperative fluorescence image guided approach with Bevacizumab-IRDye 800CW

Study design: Cholangiocarcinoma arises from varying locations within the biliary tree and is difficult to diagnose due to the often-silent clinical nature. The best chance of long-term survival is surgical resection with negative surgical margins, however most patients have unresectable disease at clinical presentation, and prognosis is very poor.

There is a need for better visualization of tumor tissue, lymph nodes and resection margins during surgery for perihilar cholangiocarcinoma (PHCC). In addition, pre-operative endoscopic diagnosis is difficult due to the lack of defining features on imaging and poor sensitivity of tissue sampling. Optical molecular imaging of PHCC associated biomarkers is a promising technique to accommodate these needs. A potential target is Vascular Endothelial Growth Factor (VEGF-A) which has been shown to be overexpressed in cholangiocarcinoma. This pilot study will determine if it is possible to detect PHCC intraoperatively and during ex-vivo NIR endoscopy by targeting VEGF-A using the tracer Bevacizumab-IRDye 800CW.

Objectives: In this pilot study, we will determine if it is possible to detect PHCC intraoperatively and by ex vivo NIR endoscopy using bevacizumab 800CW, and which tracer dose gives the best target-to-background ratio. The most optimal tracer dose will be selected for a future phase II trial

 Study population: A total of 15 patients with clinical suspicion of perihilar cholangiocarcinoma who are scheduled to undergo surgical resection with curative intent will be included in the study.

Status: Recruiting

Read more

Phase I – AVIATOR-study

 Title: Fluorescence Imaging for the Evaluation of Disease Activity in IBD and Rheumatoid Arthritis using the Fluorescent Tracer OTL38 Targeting the Folate β-receptor: a single-center pilot study

Study design: The current study is a non-randomized, non-blinded, prospective, single-center feasibility study. This study consists of two cohorts: a RA cohort and an IBD cohort consisting of an ulcerative colitis group and Crohn’s disease group. Both cohorts will receive an intravenous dose of 0.0125 mg/kg OTL38 2-3 hours before imaging. Before, during and after infusion, the vital signs will be monitored. Hands of patients with rheumatoid arthritis will be imaged with a wide-field fluorescence camera and MDSFR/SFF spectroscopy. IBD patients will be imaged with fluorescence endoscopy, MDSFR/SFF spectroscopy and confocal endomicroscopy (CLE). Furthermore, biopsies will be taken from non-inflamed and inflamed gut mucosa in IBD patients.

Objectives: The main objective is to determine the feasibility of molecular fluorescence imaging using the tracer OTL38 targeting the folate β receptor on activated macrophages for the evaluation of disease activity in patients with either RA or IBD (Crohn’s disease or ulcerative colitis). Furthermore, the safety of OTL38 will be determined by monitoring of vital signs during and after tracer infusion and evaluating possible (severe) adverse events (SAE/AEs).

Study population: Patients either diagnosed with active Rheumatoid Arthritis (RA) in one or both hands or active ulcerative colitis or Crohn’s disease by their physician and therefore switching to (another) biological(s). A total of 10 rheumatoid arthritis, 10 ulcerative colitis and 10 Crohn’s disease patients will included in this study.

Status: Waiting for IRB approval