Actively Recruiting

Age: 18Years +
All Genders
ID06894082

Cooperation Between Medical Electroradiology Manipulator and Radiologist in Tumor Imaging Assessments Using RECIST 1.1: CIMER-IPC 2023-030

Led by Institut Paoli-Calmettes · Updated on 2025-03-25

87

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the collaboration between medical electroradiology manipulators (MEMs) and radiologists in interpreting imaging scans for solid cancers using the RECIST 1.1 standard. This observational study aims to assess how MEMs contribute to identifying and measuring cancer lesions, helping to reduce radiologists' workload and enhance report quality. The study focuses on patients already enrolled in oncology protocols requiring RECIST 1.1-based scan evaluations. The study involves a baseline scan interpreted without the radiologist knowing the patient's study status to avoid bias. Then, MEMs conduct a preliminary analysis of the scans, including target and non-target lesions and any new lesions, presenting their findings in a structured format to assist radiologists. This cooperative approach is intended to improve assessment accuracy and speed, with the radiologist validating the MEM's work. The study period lasts up to 24 weeks. Participants will undergo regular imaging evaluations based on their existing cancer protocols. Researchers will assess the quality and accuracy of MEMs' pre-filling work, the benefits to both radiologists and MEMs, and any improvements in clinical research associate processes. Outcomes focus on the detection and measurement of lesions and the overall impact of this collaboration on tumor imaging assessments. Participants' medical follow-up continues as usual throughout the study.

CONDITIONS

Brief Title

Study of Radiology Manipulator Work Validation by the Radiologist

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patients with lymphoma or leukemia
  • Patient contraindicated to iodinated contrast media injection
  • Person in an emergency situation, under legal protection (guardianship, curatorship, or safeguard of justice), or unable to express non-opposition to participate
  • Unable to undergo medical follow-up for geographical, social, or psychological reasons
  • Patient with renal insufficiency or allergy preventing iodinated contrast injection during the trial
  • Patient refusing iodinated contrast injection during the study
  • Patient withdrawn from the study including scanner interpretation in RECIST 1.1

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 24 weeks

Participants undergo baseline and follow-up imaging assessments to evaluate tumor status using RECIST 1.1 criteria.

Baseline and evaluation examinations generally every 6 weeks

Trial Site Locations

Total: 1 location

1

Institut PAoli Camettes

Marseille, Institut Paoli Calmettes, France, 13009

Actively Recruiting

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Research Team

J

Jihane PAKRADOUNI, Pr

A

Allison Arthur, Mme

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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