Clinical trial NCT02129933: VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions
Official title: A Pilot Intervention Study for the Use of VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Esophageal Cancer
Dysplasia
Keywords: EAC
HGD
Esophagus
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 14
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. We hypothesize that when bevacizumab-IRDye800CW is administered, it accumulates in VEGF expressing high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC), enabling early cancer visualization using a newly developed fluorescent NIR fiber-bundle. This hypothesis will be tested in this pilot intervention study.


Eligibility criteria: Inclusion Criteria:

* Identified HGD or intramucosal EAC (T1) and therefore candidate for endoscopic mucosal resection therapy
* Mentally competent person, 18 years or older.
* Written informed consent.
* Adequate potential for follow-up.

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* Submucosal and invasive EAC; EAC with tumor-classification other than T1.
* Concurrent (uncontrolled) medical conditions which disqualify for an endoscopic mucosal resection procedure.
* Previously performed therapeutic endoscopic procedures.
* Pregnancy or breast feeding.

Primary outcomes:
measure: NIR fluorescent signal in vivo (prior to EMR)
timeFrame: 1 day (endoscopy-day)
Secondary outcomes:
measure: Number of participants with adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR).
timeFrame: Two days prior and up to 1 week after administration of tracer
measure: VEGF expression ex vivo
timeFrame: up to 1 year
measure: NIR fluorescent signal in vivo (wound bed, post EMR)
timeFrame: 1 day (endoscopy-day)
measure: NIR fluorescent signal ex vivo (biopsy and EMR specimen)
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Wouter B Nagengast, PharmD MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Frans TM Peters, MD PhD
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.