Study of Radiology Manipulator Work Validation by the Radiologist
ConditionSolid Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Paoli-Calmettes
About this trial
The main objective of this study is to evaluate the pre-filling work on target and non-target lesions, and the detection of any new lesions reported by the MEM trained in protocol evaluations, in a structured table to prepare the radiologist's work in interpreting RECIST 1.1 scans.
To meet this objective, patients taking part in the CIMER study will first have been included in a research protocol requiring scans with RECIST 1.1 interpretation.
The Baseline examination will be performed and interpreted according to RECIST 1.1 without informing the radiologist performing the reading that the patient is included in the study, so as not to introduce an interpretation bias.
During the first evaluation. The investigating MEM alone will carry out a preliminary analysis of the first evaluation and will present his results to the radiologist in charge of the evaluation, who will validate the conformity of the results.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged 18 and over
Patient included in a clinical research protocol in oncology for solid cancer including RECIST 1.1 interpretation
Disease measurable according to RECIST 1.1
Patient not objecting to study participation
Disqualifiers
Patient with renal insufficiency or allergy during the trial no longer allowing injection of iodinated contrast medium
Patient refusing iodinated PDC injection during the study
Patient withdrawn from the study including scanner interpretation in Recist 1.1
Trial population
major solid-cancer patient with baseline scan according to recists 1.1
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Evaluate the pre-filling work on target and non-target lesions and the detection of any new lesions reported by the MEM trained in protocol evaluations in a structured table in order to prepare the radiologist's work in interpreting RECIST 1.1 scans.
Measurement of the rate of validation by the radiologist of the MEM's RECIST1.1 pre-analysis work, covering respectively assessment of target lesions, assessment of non-target lesions, detection of new lesions lesions, detection of new lesions and overall disease assessment on the first evaluation.
Time frame
up to 24 weeksSecondary outcomes
1
Evaluate the benefit to the radiologist
Analysis of responses to radiologist questionnaires through a satisfaction survey created by our interdisciplinary team in economic and social sciences. There is no sharing of a common unit of measure, there is a only one questionnaire
Time frame
up to 24 weeks2
Measure the MEM's expertise in identifying possible errors in the application of RECIST criteria to the Baseline review.
Measurement of the validation rate by the radiologist of the RECIST 1.1 retrospective critical analysis of the MEM of the Baseline examination.
Time frame
up to 24 weeks3
Evaluate the benefit to the MEM
Analysis of responses to questionnaires completed by the MEM through a satisfaction survey created by our interdisciplinary team in economic and social sciences . There is no sharing of a common unit of measure, there is a only one questionnaire
Time frame
up to 24 weeks4
Evaluate the benefits to the clinical research associate
Analysis of responses to questionnaires completed by the clinical research associate through a satisfaction survey created by our interdisciplinary team in economic and social sciences. There is no sharing of a common unit of measure, there is a only one questionnaire
Time frame
up to 24 weeksSponsors and contacts
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Source ClinicalTrials.gov