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Completed

NCT Number: NCT02526134

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radio opaque markers (Echo Tip Ultra Fiducial Needle - ETUF)

Device

Primary outcomes

  1. 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.

    Time frame: From inclusion to 12 months follow up

    Observing whether there is a significant variation of the area to be irradiated

Secondary outcomes

  1. 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)

    Time frame: From inclusion to 12 months follow up

    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.

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Collaborators

  • Cook medical laboratory

Registry information

Acronym: FIDUCOR

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2015
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.