Clinical trial NCT03877601: Detection of Early Esophageal Cancer by NIR-FME.
Official title: A Prospective Follow-up Intervention Study: Detection of Early Esophageal Cancer by Near-infrared Fluoresence Molecular Endoscopy Using Bevacizumab-800CW
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Barrett Esophagus
Keywords: Fluorescence
Endoscopy
Bevacizumab-800CW
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Helmholtz Zentrum München
First posted: 2019-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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. It is known that the biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in dysplastic and neoplastic areas in BE segments versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. The phase I study, named VICE, completed within the UMCG, 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 topically applied tracer approach compared with HD-WL/NBI endoscopy. With this phase 2 intervention study the investigators 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.

Detailed description: See brief summary

Eligibility criteria: Inclusion Criteria:

* Suspicion or diagnosed LGD, HGD or superficial EAC and planned diagnostic and/or therapeutic endoscopy.
* Age: 18 years or older.
* Written informed consent.

Exclusion Criteria:

* Patients younger than 18 years old
* Submucosal and invasive EAC; EAC with TNM-classification other than T1.
* Radiation therapy for esophageal cancer
* Immunoglobulin allergy
* Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer
* Prior Bevacizumab treatment
* Non-adjustable hypertension
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* Pregnancy or breast feeding.

Primary outcomes:
measure: Fluorescence signal in patients with Barrett's Esophagus
timeFrame: During the endoscopic procedure
Secondary outcomes:
measure: Ex vivo fluorescence singals
timeFrame: 2 years
measure: Number of participants with adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR).
timeFrame: Up to 1 week after administration of tracer
measure: Interrogate potential new EC biomarkers
timeFrame: 2 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: W.B. Nagengast, MD, PhD, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helmholtz Zentrum München
name: Vasilis Ntziachristos, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nagengast WB, Hartmans E, Garcia-Allende PB, Peters FTM, Linssen MD, Koch M, Koller M, Tjalma JJJ, Karrenbeld A, Jorritsma-Smit A, Kleibeuker JH, van Dam GM, Ntziachristos V. Near-infrared fluorescence molecular endoscopy detects dysplastic oesophageal lesions using topical and systemic tracer of vascular endothelial growth factor A. Gut. 2019 Jan;68(1):7-10. doi: 10.1136/gutjnl-2017-314953. Epub 2017 Dec 15. No abstract available.