Solid CancerCimerNCT06894082
Study of Radiology Manipulator Work Validation by the Radiologist
An observational study of Solid Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancer
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2024to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: major solid-cancer patient with baseline scan according to recists 1.1
Who may be able to join
- 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:
Show all 11Show fewer
- 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.
Who cannot join
- 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- Patient withdrawn from the study including scanner interpretation in Recist 1.1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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut PAoli Camettes
Marseille, Institut Paoli Calmettes, 13009
About this study
Official title: COOPERATION BETWEEN THE MEDICAL ELECTRORADIOLOGY MANIPULATOR (MEM) AND THE RADIOLOGIST IN TUMOR IMAGING ASSESSMENTS: CIMER-IPC 2023-030
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.
Read more
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.
Read the detailed description
In recent years, imaging has become essential in the evaluation of treatment efficacy in medical oncology . As a result, the proportion of clinical trials involving imaging has risen sharply, and radiology departments are faced with the problem of work overload in the face of complex specific interpretation methods which have developed further recently with immunotherapies (iRECIST 2017, imRECIST 2018).
The RECIST 1.1 method is the reference method for evaluating treatments of solid cancers because it allows standardization, reproducibility and a common language between all stakeholders.
Interpretation is based on :A pre-treatment examination called Baseline, which defines the lesions to be monitored and evaluation examinations (generally every 6 weeks) to compare measurements and define overall tumor evolution (Complete Response, Partial Response, Stable Disease, Progressive Disease).
It is difficult to concentrate the increasing number of protocol examinations on a small number of radiologists. As a result, the number of radiologists involved in these assessments multiplies the difficulties and risks of error. For the past 2 years, the Institut Paoli Calmettes has been testing cooperative protocol readings between radiologists and medical electroradiology manipulators (MEMs). First impressions are encouraging, and show that both radiologists and investigators are satisfied, with a priori an increase in the quality of radiological reports and a saving in interpretation time that we hope to objectify. This type of organization has already been partly studied in other Cancer Centers, such as the Centre Antoine Lacassagne in Nice and the Centre Henri Becquerel in Rouen, demonstrating the effectiveness of manipulators in measuring target lesions.
Artificial Intelligence solutions are currently being developed in all areas of imaging, opening up the possibility of applications to RECIST assessments). While these solutions appear to be of interest for the reassessment of previously identified lesions, their limitations for the time being relate to the differentiation between malignant lesions and benign tissue. The aim of adding AI to human analyses would be to further improve measurement performance and speed of assessment, without replacing but implementing the contribution that specialized manipulators could already make to radiological interpretations. In a difficult period for the radiology manipulator profession, these proposed new skills may also give new interest to the profession by integrating into an advanced practice pathway for which radiologists remain responsible. The aim of this study is to evaluate the contribution of collaboration with a manipulator specialized in therapeutic trials for the radiologist in charge of interpretation.
It aims to redefine the sharing of activities between delegators (mainly doctors) and other healthcare professionals (receiving delegation, or delegates), by entrusting the latter with certain activities outside their usual remit, in order to free up medical time while making the careers of these healthcare professionals more attractive.
The innovative nature of this cooperation would highlight the value of radiologist/EMM collaboration in intellectual acts.
It is not possible to compare 2 cohorts of patients in order to objectivize the contribution of manipulators to patient care, as the difficulty and time required to interpret RECIST 1.1 vary greatly from one patient to another, and depend mainly on the type of disease and its extent on the scanner.
Thus, 2 groups of patients comparable in terms of difficulty and interpretation time cannot be composed. For this reason, the study is based on the radiologist's assessment of the assistance provided by the MEM.
- Conditions
- Solid Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 weeks
Secondary outcomes (4)
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
Measured: up to 24 weeks
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.
Measured: up to 24 weeks
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
Measured: up to 24 weeks
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
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start12 Dec 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894082
- Sponsor's protocol ID
- CIMER-IPC 2023-030
- Other IDs
- health data hub
- Acronym
- Cimer
- Status last verified
- Mar 2025
- First submitted
- 25 Nov 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COOPERATION BETWEEN THE MEDICAL ELECTRORADIOLOGY MANIPULATOR (MEM) AND THE RADIOLOGIST IN TUMOR IMAGING ASSESSMENTS: CIMER-IPC 2023-030
- ClinicalTrials.gov ID
- NCT06894082
- Acronym / sponsor ID
- Cimer / CIMER-IPC 2023-030
- Conditions
- Solid Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In recent years, imaging has become essential in the evaluation of treatment efficacy in medical oncology . As a result, the proportion of clinical trials involving imaging has risen sharply, and radiology departments are faced with the problem of work overload in the face of complex specific interpretation methods which have developed further recently with immunotherapies (iRECIST 2017, imRECIST 2018).
The RECIST 1.1 method is the reference method for evaluating treatments of solid cancers because it allows standardization, reproducibility and a common language between all stakeholders.
Interpretation is based on :A pre-treatment examination called Baseline, which defines the lesions to be monitored and evaluation examinations (generally every 6 weeks) to compare measurements and define overall tumor evolution (Complete Response, Partial Response, Stable Disease, Progressive Disease).
It is difficult to concentrate the increasing number of protocol examinations on a small number of radiologists. As a result, the number of radiologists involved in these assessments multiplies the difficulties and risks of error. For the past 2 years, the Institut Paoli Calmettes has been testing cooperative protocol readings between radiologists and medical electroradiology manipulators (MEMs). First impressions are encouraging, and show that both radiologists and investigators are satisfied, with a priori an increase in the quality of radiological reports and a saving in interpretation time that we hope to objectify. This type of organization has already been partly studied in other Cancer Centers, such as the Centre Antoine Lacassagne in Nice and the Centre Henri Becquerel in Rouen, demonstrating the effectiveness of manipulators in measuring target lesions.
Artificial Intelligence solutions are currently being developed in all areas of imaging, opening up the possibility of applications to RECIST assessments). While these solutions appear to be of interest for the reassessment of previously identified lesions, their limitations for the time being relate to the differentiation between malignant lesions and benign tissue. The aim of adding AI to human analyses would be to further improve measurement performance and speed of assessment, without replacing but implementing the contribution that specialized manipulators could already make to radiological interpretations. In a difficult period for the radiology manipulator profession, these proposed new skills may also give new interest to the profession by integrating into an advanced practice pathway for which radiologists remain responsible. The aim of this study is to evaluate the contribution of collaboration with a manipulator specialized in therapeutic trials for the radiologist in charge of interpretation.
It aims to redefine the sharing of activities between delegators (mainly doctors) and other healthcare professionals (receiving delegation, or delegates), by entrusting the latter with certain activities outside their usual remit, in order to free up medical time while making the careers of these healthcare professionals more attractive.
The innovative nature of this cooperation would highlight the value of radiologist/EMM collaboration in intellectual acts.
It is not possible to compare 2 cohorts of patients in order to objectivize the contribution of manipulators to patient care, as the difficulty and time required to interpret RECIST 1.1 vary greatly from one patient to another, and depend mainly on the type of disease and its extent on the scanner.
Thus, 2 groups of patients comparable in terms of difficulty and interpretation time cannot be composed. For this reason, the study is based on the radiologist's assessment of the assistance provided by the MEM.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- major solid-cancer patient with baseline scan according to recists 1.1
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: up to 24 weeks
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.
4 secondary outcomes
Evaluate the benefit to the radiologist
Time frame: up to 24 weeks
Measure the MEM's expertise in identifying possible errors in the application of RECIST criteria to the Baseline review.
Time frame: up to 24 weeks
Evaluate the benefit to the MEM
Time frame: up to 24 weeks
Evaluate the benefits to the clinical research associate
Time frame: up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Cancer, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihane PAKRADOUNI, Pr (0491223824, pakradounij@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.