MedDataX Logo

Feasibility Study of Fiducial Markers in Oesophageal Cancer

NCT ID: NCT02403050

Last Updated: 2015-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Currently, patients of suitable fitness with non-metastatic esophageal cancer are treated with surgery, radiotherapy or chemoradiotherapy. If treated with radio or chemoradiotherapy, a Computerised tomography (CT) scan is performed and is the dataset used for planning radiotherapy. Information from the endoscopic ultrasound (EUS), performed during routine staging, is used to help localize the tumor, as tumors of the esophagus are poorly visualised on CT. This information is subjective and dependant on the clinician performing the procedure. The tumor is described in relation to common anatomical landmarks. Interpretion of this information can lead to over-compensation when attempting to cover the tumor with a radiation field, to avoid a "miss". It is thought that using fiducial markers called Visicoils placed in or adjacent to the tumor's top and bottom extent at the time of EUS, will lead to better definition of the tumor in the planning process and hence, improvement in local tumor control, and reduction in radiotherapy dose to normal tissue.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Neoplasm Staging Radiotherapy Fiducial Markers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fiducial Markers Prospective cohort

2 fiducial markers (Visicoils) to be placed in the tumor area at the routine endoscopic ultrasound (EUS) appointment.

Fiducial markers

Intervention Type DEVICE

2 fiducial markers (Visicoils) to be placed in the tumor area

Retrospective cohort

Images and clinical data from a retrospective group of patients without fiducial markers

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fiducial markers

2 fiducial markers (Visicoils) to be placed in the tumor area

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* esophageal adenocarcinoma or squamous carcinoma, or undifferentiated carcinoma.
* No previous radiotherapy or chemotherapy.
* Fit for radical treatment of their cancer with reasonable lung function, Fev1 \>40%, and EUS planned.
* ECOG Performance Status 0-1: 0 - Fully active, able to carry on all predisease performance without restriction 1 - Restricted in physically strenuous activity

Exclusion Criteria

* Pregnancy or breast feeding.
* Allergy to ciprofloxacin antibiotics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vivienne MacLaren, MBChB, FRCP

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow & Clyde

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beatson Oncology Centre

Glasgow, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Vivienne MacLaren, MBChB, FRCP

Role: CONTACT

Phone: 441413017093

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Vivienne MacLaren, MBChB, MRCP

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GN14ON144

Identifier Type: -

Identifier Source: org_study_id