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OpenTrials
Completed

NCT Number: NCT03956459

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 > 70.
  • 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

Treatment and study plan

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

Other

For each patient, 2 consecutive PET-CT scanners will be performed using 2 different systems of PET-CT scanners:

  • "Discovery MI"
  • "Discovery IQ"

Only one contrast agent injection (FDG) will be given for both scanners.

Primary outcomes

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

    Time frame: 24 hours for each patient

Secondary outcomes

  1. Rate of Inter-observer concordance in radiological images interpretation

    Time frame: 24 hours for each patient

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: IQversusMI

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 20, 2019
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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