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Clinical Trials/NCT03956459
NCT03956459
Completed
Not Applicable

Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer

Institut Claudius Regaud1 site in 1 country24 target enrollmentJuly 25, 2019

Overview

Phase
Not Applicable
Intervention
Patients with a cancer for which a FDG-PET scanner must be performed
Conditions
Cancer
Sponsor
Institut Claudius Regaud
Enrollment
24
Locations
1
Primary Endpoint
Relative rate of virtual lesions detected by each system ("Discovery MI" and "Discovery IQ")
Status
Completed
Last Updated
18 days ago

Overview

Brief Summary

Prospective, monocentric study aiming to evaluate the PET-CT (Positron Emission Tomography - Computed Tomography) scanner performances to detect infra-centimetric lesions in two groups of patients with cancer and of different BMI (Body Mass Index) classes (BMI ≤ 25 and BMI > 25).

For each patient, two consecutive PET-CT scanner will be performed using the "Discovery MI" and "Discovery IQ" PET-CT scanner systems.

Virtual lesions will then be created on images obtained. Images will be interpreted by two independent observers.

The study participation of each patient will be a maximum of 24 hours.

Registry
clinicaltrials.gov
Start Date
July 25, 2019
End Date
February 4, 2021
Last Updated
18 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years old.
  • A patient with a cancer for which a FDG-PET (fluorodeoxyglucose-positron emission tomography) must be performed according to the standard practices
  • OMS ≤ 1, Karnofsky Index \>
  • Negative pregnancy test at inclusion.
  • Patient able to maintain a lying position in a strict supine position twice.
  • Patient affiliated to a Social Health Insurance in France.
  • Patient who has signed informed consent prior inclusion in the study and before any specific procedures for the study.

Exclusion Criteria

  • Patient with unbalanced diabetic
  • Patient with a formal contraindication usual for certain imaging procedures (severe claustrophobia, wearing a heart valve, pacemaker, etc.)
  • Pregnant or breastfeeding woman
  • Any psychological, family, geographical or sociological condition that does not allow medical follow-up and/or procedures provided for in the study protocol to be respected
  • Patient protected by law

Arms & Interventions

Patients with a cancer

Intervention: Patients with a cancer for which a FDG-PET scanner must be performed

Outcomes

Primary Outcomes

Relative rate of virtual lesions detected by each system ("Discovery MI" and "Discovery IQ")

Time Frame: 24 hours for each patient

Secondary Outcomes

  • Rate of Inter-observer concordance in radiological images interpretation(24 hours for each patient)

Study Sites (1)

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