Study of Radiology Manipulator Work Validation by the Radiologist

NCT06894082 | Recruiting DMC

• 2 other identifiers: CIMER-IPC 2023-030health data hub
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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. 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

Solid Cancer

Outcome Measures

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.

  up to 24 weeks

Secondary Outcomes (4)

• Evaluate the benefit to the radiologist

  up to 24 weeks

• Measure the MEM's expertise in identifying possible errors in the application of RECIST criteria to the Baseline review.

  up to 24 weeks

• Evaluate the benefit to the MEM

  up to 24 weeks

• Evaluate the benefits to the clinical research associate

  up to 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

major solid-cancer patient with baseline scan according to recists 1.1

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut PAoli Camettes

Marseille, Institut Paoli Calmettes, 13009, France

RECRUITING

Central Study Contacts

Jihane PAKRADOUNI, Pr

CONTACT

0491223824; pakradounij@ipc.unicancer.fr

Allison Arthur, Mme

CONTACT

0491223448; arthura@ipc.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: March 25, 2025
• Study Start: December 12, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

FR (1)