Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03205501
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2017-06-29
Brief Title:
Molecular Fluorescence Endoscopy of PreMalignant Esophageal Lesions
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Molecular Fluorescence Endoscopy for the Detection of PreMalignant Lesions in Barretts Esophagus Using a Fluorescent Tracer EMI-137 Targeting c-Met a Single-center Feasibility and Safety Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EAGLE
Brief Summary:
To improve detection of esophageal premalignant lesions during surveillance endoscopy of patients at risk of developing malignancies for example in Barretts 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 c-Met is overexpressed in dysplastic and neoplastic areas in BE segments versus normal tissue and has proven to be a valid target for molecular imaging
Edinburgh Molecular Imaging Ltd EMI has developed a fluorescent tracer specifically targeting c-Met by labeling a small peptide to a fluorescent fluorophore EMI-137 The investigators hypothesize that when EMI-137 is administered intravenously it accumulates in c-Met expressing high grade dysplasia HGD and esophageal adenocarcinoma EAC enabling early cancer visualization using a newly developed fluorescent fiber-bundle This hypothesis will be tested in the current pilot intervention study
Edinburgh Molecular Imaging Ltd EMI has developed a fluorescent tracer specifically targeting c-Met by labeling a small peptide to a fluorescent fluorophore EMI-137 The investigators hypothesize that when EMI-137 is administered intravenously it accumulates in c-Met expressing high grade dysplasia HGD and esophageal adenocarcinoma EAC enabling early cancer visualization using a newly developed fluorescent fiber-bundle This hypothesis will be tested in the current pilot intervention study
Detailed Description:
See brief summary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None