Detection of early stages of esophageal cancer with fluorescence molecular endoscopy.

Detection of Early Esophageal Cancer by Near-Infrared Fluorescence molecular Endoscopy using Bevacizumab-800CW - Fluorescence endoscopy of early stages of esophageal cancer.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004745-17-NL

Enrollment

Registered

2019-01-31

Start date

2019-03-28

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Barretts esophagus and there is a suspicion for at least low grade dysplasia.

Interventions

Product Name: Bevacizumab-IRDye800CW Product Code: Bevacizumab-IRDye800CW Pharmaceutical Form: Suspension and solution for spray INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Suspicion or diagnosed LGD, HGD or superficial EAC and planned diagnostic and/or therapeutic endoscopy. Mentally competent person, 18 years or older. dequate potential for 5-year follow-up. Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: An interim analysis will be conducted by the investigators involved in this study after the first 15 patients. The interim analysis will include the primary endpoint as well as key safety parameters. ;Main Objective: To evaluate the performance of FME with topical administration of Bevacizumab-800CW for detection of neoplasia in BE patients compared to HD-WLE to make an estimation of the diagnostic accuracy in terms of sensitivity and specificity in order to make a power size calculation for the Phase III trial.;Secondary Objective: To collect more safety data of topical administration, by spraying Bevacizumab-IRDye800CW. Quantify in vivo the NIR fluorescent signal of Bevacizumab-800CW by means of the MDSFR/SFF spectroscopy probe. To evaluate the degree of in vivo fluorescence intensity and ex vivo grade of VEGF expression for the different stages of esophageal dysplasia-carcinoma sequence. Interrogate new EC targets derived from our recent findings on EC dysplasia targets to further improve EC detection by multi parametric examination and disease stratification over using Bevacizumab-IRDye800CW. Eventually further specify and objectify the improvement of NIR-FME leading to reduction of unnecessary biopsies. Investigate the improvement of speed, efficiency and quality of the NIR-FME examination. ;Primary end point(s): - Macroscopic fluorescent signal levels and tracer distribution observed by flexible fluorescence molecular endoscopy. - Macroscopic quantification of the fluorescent signal observed by means of the MDSFR/SFF spectroscopy probe. - Microscopic distribution and (semi-quantitative) fluorescent signal intensity of bevacizumab-IRDye800CW in the EMR specimen and biopsies correlated to VEGF distribution and level of expression. - Ex-vivo we will perform binding experiments with tracers against GREM1, -SULF1 and –PRKCi on the fresh EMR and surgical EC specimen if available and compare them against the in-vivo W	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: An interim analysis will be conducted by the investigators involved in this study after the first 15 patients. The interim analysis will include the primary endpoint as well as key safety parameters. ;Main Objective: To evaluate the performance of FME with topical administration of Bevacizumab-800CW for detection of neoplasia in BE patients compared to HD-WLE to make an estimation of the diagnostic accuracy in terms of sensitivity and specificity in order to make a power size calculation for the Phase III trial.;Secondary Objective: To collect more safety data of topical administration, by spraying Bevacizumab-IRDye800CW. Quantify in vivo the NIR fluorescent signal of Bevacizumab-800CW by means of the MDSFR/SFF spectroscopy probe. To evaluate the degree of in vivo fluorescence intensity and ex vivo grade of VEGF expression for the different stages of esophageal dysplasia-carcinoma sequence. Interrogate new EC targets derived from our recent findings on EC dysplasia targets to further improve EC detection by multi parametric examination and disease stratification over using Bevacizumab-IRDye800CW. Eventually further specify and objectify the improvement of NIR-FME leading to reduction of unnecessary biopsies. Investigate the improvement of speed, efficiency and quality of the NIR-FME examination. ;Primary end point(s): - Macroscopic fluorescent signal levels and tracer distribution observed by flexible fluorescence molecular endoscopy. - Macroscopic quantification of the fluorescent signal observed by means of the MDSFR/SFF spectroscopy probe. - Microscopic distribution and (semi-quantitative) fluorescent signal intensity of bevacizumab-IRDye800CW in the EMR specimen and biopsies correlated to VEGF distribution and level of expression. - Ex-vivo we will perform binding experiments with tracers against GREM1, -SULF1 and –PRKCi on the fresh EMR and surgical EC specimen if available and compare them against the in-vivo W

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Secondary

Measure	Time frame
Secondary end point(s): - The correlation between fluorescence intensity and the grade of VEGF expression on immunohistochemistry, in (pre)malignant lesions of the esophagus. - Adverse events (AE), serious adverse events (SAE), and suspected unexpected serious adverse reactions (SUSARs). Patient characteristics (age, sex, BMI, history and morbidity, presence of GERD, treatment outcome, prior BE diagnosis and classification, blood pressure, oxygen saturation, and temperature during the procedure). - EMR specimen and biopsy characteristics (grade of dysplasia or tumor stage, size and/or piecemeal resection, resection margins, presence of metachronous dysplastic lesions) - Histopathologic examinations related to ex vivo VEGF expression and bevacizumab-IRDye800CW distribution. ;Timepoint(s) of evaluation of this end point: An interim analysis will be conducted by the investigators involved in this study after the first 15 patients. The interim analysis will include the primary endpoint as well as key safety parameters.	—

Measure

Time frame

Secondary end point(s): - The correlation between fluorescence intensity and the grade of VEGF expression on immunohistochemistry, in (pre)malignant lesions of the esophagus. - Adverse events (AE), serious adverse events (SAE), and suspected unexpected serious adverse reactions (SUSARs). Patient characteristics (age, sex, BMI, history and morbidity, presence of GERD, treatment outcome, prior BE diagnosis and classification, blood pressure, oxygen saturation, and temperature during the procedure). - EMR specimen and biopsy characteristics (grade of dysplasia or tumor stage, size and/or piecemeal resection, resection margins, presence of metachronous dysplastic lesions) - Histopathologic examinations related to ex vivo VEGF expression and bevacizumab-IRDye800CW distribution. ;Timepoint(s) of evaluation of this end point: An interim analysis will be conducted by the investigators involved in this study after the first 15 patients. The interim analysis will include the primary endpoint as well as key safety parameters.

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Countries

Netherlands

Contacts

Public ContactDepartment of Gastroenterology

University Medical Center Groningen

w.b.nagengast@umcg.nl0031503612620

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026