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Detection of Early Esophageal Cancer by NIR-FME.

NCT ID: NCT03877601

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-29

Study Completion Date

2021-10-01

Brief Summary

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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

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See brief summary

Conditions

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Barrett Esophagus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Topical administration of bevacizumab-800CW

The tracer will be topically administered 5 minutes prior to the fluorescence endoscopy procedure (with the near infrared fluorescence endoscopy platform).

Group Type EXPERIMENTAL

Bevacizumab-IRDye800CW

Intervention Type DRUG

Topical administration of Bevacizumab-IRDye800CW during the endoscopic procedure.

Fluorescence endoscopy

Intervention Type DIAGNOSTIC_TEST

Device: Molecular Fluorescence Endoscopy platform A flexible fluorescence fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fiber-probe is inserted through the standard working channel of the standard clinical endoscope.

Interventions

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Bevacizumab-IRDye800CW

Topical administration of Bevacizumab-IRDye800CW during the endoscopic procedure.

Intervention Type DRUG

Fluorescence endoscopy

Device: Molecular Fluorescence Endoscopy platform A flexible fluorescence fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fiber-probe is inserted through the standard working channel of the standard clinical endoscope.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helmholtz Zentrum München

INDUSTRY

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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dr. W.B. Nagengast, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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W.B. Nagengast, MD, PhD, PharmD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Vasilis Ntziachristos, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Helmholtz Zentrum München

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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W.B. Nagengast, MD, PhD, PharmD

Role: CONTACT

[email protected]
+31503612620

R.Y. Gabriels, MSc, MD

Role: CONTACT

[email protected]
+31615691998

Facility Contacts

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W B Nagengast, MD, PhD, PharmD

Role: primary

[email protected]
+31503612620

References

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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.

Reference Type BACKGROUND
PMID: 29247063 (View on PubMed)

Other Identifiers

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NL68582.042.18

Identifier Type: -

Identifier Source: org_study_id