This trial is active, not recruiting.

Conditions oesophageal cancer, rectal cancer
Treatment radio opaque markers (echo tip ultra fiducial needle - etuf)
Phase phase 2
Sponsor Institut Paoli-Calmettes
Collaborator Cook medical laboratory
Start date April 2014
End date January 2017
Trial size 29 participants
Trial identifier NCT02526134, FIDUCOR-IPC 2013-008


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
radio opaque markers
radio opaque markers (echo tip ultra fiducial needle - etuf)

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Institut Paoli-Calmettes.