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Detection of Early Esophageal Cancer by NIR-FME. (ESCEND)

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ClinicalTrials.gov Identifier: NCT03877601
Recruitment Status : Unknown
Verified November 2020 by dr. W.B. Nagengast, MD, University Medical Center Groningen.
Recruitment status was:  Recruiting
First Posted : March 15, 2019
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Helmholtz Zentrum München
Information provided by (Responsible Party):
dr. W.B. Nagengast, MD, University Medical Center Groningen

Tracking Information
First Submitted Date  ICMJE February 27, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE July 29, 2019
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
Fluorescence signal in patients with Barrett's Esophagus [ Time Frame: During the endoscopic procedure ]
Evaluating 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • Ex vivo fluorescence singals [ Time Frame: 2 years ]
    Correlate and validate fluorescence signals detected in vivo with ex vivo histopathology grade of dysplasia and VEGF expression
  • Number of participants with adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR). [ Time Frame: Up to 1 week after administration of tracer ]
    Data collection as a measure of safety and tolerability regarding administration of Bevacizumab-IRDye800CW
  • Interrogate potential new EC biomarkers [ Time Frame: 2 years ]
    We will perform ex-vivo binding experiments with tracers against GREM1, -SULF1 and -PRKCi on the fresh EMR if available and compare them against the in-vivo WLE/NIR-FME findings. We will analyze the sensitivity and specificity of the novel markers alone or in combination. The targeting moieties will be coupled with different fluorophores allowing for multi-parametric analysis.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detection of Early Esophageal Cancer by NIR-FME.
Official Title  ICMJE A Prospective Follow-up Intervention Study: Detection of Early Esophageal Cancer by Near-infrared Fluoresence Molecular Endoscopy Using Bevacizumab-800CW
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Barrett Esophagus
Intervention  ICMJE
  • Drug: Bevacizumab-IRDye800CW
    Topical administration of Bevacizumab-IRDye800CW during the endoscopic procedure.
  • Diagnostic Test: 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.
Study Arms  ICMJE Experimental: 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).
Interventions:
  • Drug: Bevacizumab-IRDye800CW
  • Diagnostic Test: Fluorescence endoscopy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03877601
Other Study ID Numbers  ICMJE NL68582.042.18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party dr. W.B. Nagengast, MD, University Medical Center Groningen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Medical Center Groningen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Helmholtz Zentrum München
Investigators  ICMJE
Principal Investigator: W.B. Nagengast, MD, PhD, PharmD University Medical Center Groningen
Principal Investigator: Vasilis Ntziachristos, Prof. Dr. Helmholtz Zentrum München
PRS Account University Medical Center Groningen
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP