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Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum (FIDUCOR)

Primary Purpose

Oesophageal Cancer, Rectal Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
radio opaque markers (Echo Tip Ultra Fiducial Needle - ETUF)
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oesophageal Cancer focused on measuring Laying of medical devices (radio opaque markers)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female over the age of 18
  • Rectal cancer diagnosis or esophagus
  • Radiotherapy indication
  • Signed consent to participate
  • Patient affiliated to a social security system or benefiting from such a system

Exclusion Criteria:

  • Pregnant women, of child-bearing potential, or lactating women
  • Patient deprived of liberty or under supervision of a guardian
  • Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
  • Contra-indication for procedure study (infeasible EUS)
  • Contra-indication for general anesthesia
  • Patient (e) with disorders of hemostasis
  • Patient (e) with portal hypertension

Sites / Locations

  • Institut Paoli-Calmettes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laying of medical devices

Arm Description

radio opaque markers

Outcomes

Primary Outcome Measures

Patients rate in which a significant variation in the area to be irradiated will be observed between before evaluation and evaluation after laying the trustees.
Observing whether there is a significant variation of the area to be irradiated

Secondary Outcome Measures

Number of trustees (2 up 6 maximum) and set up their positions estimated success rate of implementation and the evaluation of the safety and toxicity (complications) associated with the establishment trustees (composite measure)
Safety and security are measured by statistical analysis (numbers and percentage for qualitative variables and by average, median, standard deviations and extreme values for quantitative variables.

Full Information

First Posted
June 25, 2015
Last Updated
March 1, 2017
Sponsor
Institut Paoli-Calmettes
Collaborators
Cook medical laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT02526134
Brief Title
Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum
Acronym
FIDUCOR
Official Title
Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
Collaborators
Cook medical laboratory

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to estimate the rate of patients in whom a significant change in the area to be irradiated will be observed between the assessment before and after laying the evaluation of Trustees.
Detailed Description
The centering of radiotherapy is done with the pre-radiation scanner for tracking the implementation of target skin markers. On this scanner, it is often difficult for the radiation therapist to pinpoint the target volume. To improve the definition of the target volume, image fusion techniques with other imaging tests were developed. To improve the pre-radiotherapy identification, setting up markers echo-endoscopy has been described without major complications. The impact on targeting radiotherapy was mainly described for the prostate. The marking of digestive tumors was described by the establishment of Trustees, radiopaque markers in the lymph nodes, esophagus, stomach, pancreas, and bile ducts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oesophageal Cancer, Rectal Cancer
Keywords
Laying of medical devices (radio opaque markers)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laying of medical devices
Arm Type
Experimental
Arm Description
radio opaque markers
Intervention Type
Device
Intervention Name(s)
radio opaque markers (Echo Tip Ultra Fiducial Needle - ETUF)
Primary Outcome Measure Information:
Title
Patients rate in which a significant variation in the area to be irradiated will be observed between before evaluation and evaluation after laying the trustees.
Description
Observing whether there is a significant variation of the area to be irradiated
Time Frame
From inclusion to 12 months follow up
Secondary Outcome Measure Information:
Title
Number of trustees (2 up 6 maximum) and set up their positions estimated success rate of implementation and the evaluation of the safety and toxicity (complications) associated with the establishment trustees (composite measure)
Description
Safety and security are measured by statistical analysis (numbers and percentage for qualitative variables and by average, median, standard deviations and extreme values for quantitative variables.
Time Frame
From inclusion to 12 months follow up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female over the age of 18 Rectal cancer diagnosis or esophagus Radiotherapy indication Signed consent to participate Patient affiliated to a social security system or benefiting from such a system Exclusion Criteria: Pregnant women, of child-bearing potential, or lactating women Patient deprived of liberty or under supervision of a guardian Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons Contra-indication for procedure study (infeasible EUS) Contra-indication for general anesthesia Patient (e) with disorders of hemostasis Patient (e) with portal hypertension
Facility Information:
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.institutpaolicalmettes.fr
Description
official web site of the sponsor

Learn more about this trial

Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum

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