A pilot intervention study for the use of VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (pre)malignant Esophageal Lesions

A pilot intervention study for the use of VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (pre)malignant Esophageal Lesions - VICE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41226

Enrollment

Registered

2014-02-13

Start date

2014-04-29

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Esophageal adenocarcinoma

Interventions

Patients included in this study will undergo an endoscopic procedure including the standard endosocpic treatment (EMR) as well as VEGF-targeted fluorescence imaging. All patients will receive the sa

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Identified high grade dysplasia (HGD) or intramucosal adenocarcinoma (EAC; T1) and therefore candidate for endoscopic therapy using EMR. - Mentally competent person, age 18 years or older - Written informed consent. - Adequate potential for follow-up.

Exclusion criteria

Exclusion criteria: - Medical or psychiatric conditions that compromise the patient*s ability to give informed consent. - Submucosal and invasive EAC ; EAC with TNM-classification other than T1 - Concurrent uncontrolled medical conditions or medical conditions which disqualify for an EMR procedure. - Previously preformed therapeutic endoscopic procedures. - Pregnancy or breast feeding.

Design outcomes

Primary

Measure	Time frame
- Macroscopic fluorescent signal levels and tracer distribution observed by flexible NIR fluorescence imaging; (semi)quantitative. - Microscopic distribution and objecifying of the fluorescent signal intensity of bevacizumab-IRDye800CW in vivo using the CLE cellvizio probe-based imaging system. - 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	—

Measure

Time frame

- Macroscopic fluorescent signal levels and tracer distribution observed by flexible NIR fluorescence imaging; (semi)quantitative. - Microscopic distribution and objecifying of the fluorescent signal intensity of bevacizumab-IRDye800CW in vivo using the CLE cellvizio probe-based imaging system. - 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

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Secondary

Measure	Time frame
- Distinguish and objectify in vivo the NIR fluorescent signal of Bevacizumab-800CW by means of the CLE cellvizio probe-based imaging system. - 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).	—

Measure

Time frame

- Distinguish and objectify in vivo the NIR fluorescent signal of Bevacizumab-800CW by means of the CLE cellvizio probe-based imaging system. - 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).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)