Esophageal Neoplasms Clinical Trial
— MuSEOfficial title:
Prospective Pilot Cohort Study to Assess Feasibility of Multi-Spectral Endoscopic Imaging for Detection of Early Neoplasia in Barrett's Oesophagus
Verified date | April 2021 |
Source | University of Cambridge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Multispectral imaging represents an exciting new field of investigation in endoscopic research. Multispectral imaging uses a specialised camera to detect multiple colours, allowing us to build a rough spectrum from each point in our image. It is widely reported that these spectra are different for different tissue types, but this is difficult to study ex vivo since de-oxygenation of the blood and decay of the tissue change these spectra considerably. The investigators have therefore designed this study to asses the different multispectral imaging spectra of Barrett's Oesophagus, which we believe might be utilised as a method to detect dysplasia in the future.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or female subjects over 18 years - Previous diagnosis of Barrett's oesophagus, with an endoscopic length of at least 2 cm - Previous diagnosis of oesophageal glandular dysplasia or early oesophageal adenocarcinoma for consideration of endoscopic therapy Exclusion Criteria: - History of oesophageal stricture precluding passage of the endoscope, - Pregnancy, or planned pregnancy during the course of the study, - Currently breastfeeding - Any history of esophageal varices, liver impairment of moderate or worse severity (Child's- Pugh class B & C) or evidence of varices on initial treatment endoscopy, - Any history of oesophageal surgery, except for uncomplicated fundoplication, and, - History of coagulopathy, with INR>1.3 and/or platelet count of <75,000. - On clopidogrel, and/or warfarin for high risk condition and unable to withhold temporarily the medication. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | MRC Cancer Unit | Cambridge |
Lead Sponsor | Collaborator |
---|---|
University of Cambridge |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of confidence in delineating the area of interest by multispectral imaging | Level of confidence in delineating the area of interest by the multispectral endoscope in terms of image quality and visibility of area of interest assessed by endoscopist using a 1 to 10 Visual Analogue Score (VAS). We will consider the following ranges 0-3 poor; 4-5 fair; 6-8 good, 9-10 excellent | 1 year | |
Secondary | Imaging spectra by multispectral endoscopy in neoplastic vs. non-neoplastic Barrett's | Number and type of image spectra corresponding to neoplastic and non-neoplastic area of Barrett's Oesophagus | 1 year | |
Secondary | Patient comfort | Patient comfort score measured by assisting nurse according to standard scoring scale (1 to 5) | 1 year | |
Secondary | Time | Time to perform multispectral imaging in minutes | 1 year | |
Secondary | Correlation with molecular biomarkers | Comparison of the biomarker features of biopsies directed by multispectral imaging (both neoplastic and non-neoplastic) using a molecular panel assessing aneuploidy, p53 and cyclin A. | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05013697 -
TQB2450 Solution for Injection (TQB2450)+Paclitaxel+Cisplatin ± Anlotinib in the Treatment of Esophageal Cancer.
|
Phase 2 | |
Completed |
NCT02253602 -
Innovative MRI Techniques to Improve Treatment Stratification of Patients With Esophageal Cancer
|
N/A | |
Completed |
NCT02128243 -
Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
|
Phase 2 | |
Completed |
NCT01900691 -
Removal of the Evolution® Esophageal Stent - Fully Covered
|
N/A | |
Completed |
NCT01719926 -
Phase I Platinum Based Chemotherapy Plus Indomethacin
|
Phase 1 | |
Terminated |
NCT01572987 -
Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus
|
N/A | |
Terminated |
NCT00760604 -
A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer
|
Phase 3 | |
Completed |
NCT00160030 -
Study Comparing Radiochemotherapy With Folfox 4 Regimen or 5FU-Cisplatin in Patients With Inoperable Esophageal Cancer
|
Phase 2 | |
Suspended |
NCT00048529 -
Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus
|
Phase 2 | |
Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 | |
Completed |
NCT02284802 -
Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy
|
N/A | |
Terminated |
NCT03223662 -
Metabolomic and BH3 Profiling of Esophageal Cancers: Identification of Novel Assessment Methods of Treatment Response for Precision Therapy
|
Phase 2 | |
Completed |
NCT05680077 -
KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
|
||
Completed |
NCT03549494 -
Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction
|
Phase 2 | |
Completed |
NCT03261947 -
A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors
|
Phase 2 | |
Terminated |
NCT00094978 -
Depsipeptide/Flavopiridol Infusion for Cancers of the Lungs, Esophagus, Pleura, Thymus or Mediastinum
|
Phase 1 | |
Recruiting |
NCT02908204 -
Long-term Outcomes of Superficial Esophageal Squamous Cell Carcinoma
|
N/A | |
Completed |
NCT02378948 -
Nutritional Route In Esophageal Resection Trial II
|
N/A | |
Completed |
NCT02703142 -
Endoscopic Evaluation After Esophagectomy
|
N/A | |
Recruiting |
NCT02604615 -
The Role of Different Cycles of Chemotherapy(Capecitabine-oxaliplatin) in Esophageal Chemoradiotherapy
|
Phase 3 |