Clinical trial · Observational
Study of Radiology Manipulator Work Validation by the Radiologist
COOPERATION BETWEEN THE MEDICAL ELECTRORADIOLOGY MANIPULATOR (MEM) AND THE RADIOLOGIST IN TUMOR IMAGING ASSESSMENTS: CIMER-IPC 2023-030
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Cancer | Malignant Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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.
- timeFrame
- up to 24 weeks
- description
- 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.
Secondary outcomes (4)
- measure
- Evaluate the benefit to the radiologist
- timeFrame
- up to 24 weeks
- description
- 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
- measure
- Measure the MEM's expertise in identifying possible errors in the application of RECIST criteria to the Baseline review.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Member of a social security scheme, or beneficiary of such a scheme. Non inclusion Criteria: * Patients with lymphoma or leukemia * Patient contraindicated to iodinated contrast media injection * Person in an emergency situation, adult subject to a legal protection measure (major under guardianship, curatorship or safeguard of justice), or unable to express, his/her non-opposition to participate in the study * Unable to undergo medical follow-up for geographical, social or psychological reasons. or psychological reasons. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available