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

NCT03956459 | Completed

• 1 other identifier: 19 GENE 03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

FDG-PET

Outcome Measures

Primary Outcomes (1)

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

  24 hours for each patient

Secondary Outcomes (1)

• Rate of Inter-observer concordance in radiological images interpretation

  24 hours for each patient

Study Arms (1)

Patients with a cancer

OTHER

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

Interventions

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.

Patients with a cancer

Eligibility Criteria

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

You may qualify if:

• 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.
• Patient able to maintain a lying position in a strict supine position twice.
• Patient affiliated to a Social Health Insurance in France.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, France

Location

Related Publications (1)

• Maronnier Q, Robaine N, Chaltiel L, Dierickx LO, Cassou-Mounat T, Terroir M, Vija L, Vallot D, Brillouet S, Lamesa C, Filleron T, Caselles O, Courbon F. Insertion of synthetic lesions on patient data: a method for evaluating clinical performance differences between PET systems. EJNMMI Phys. 2024 Jan 22;11(1):9. doi: 10.1186/s40658-023-00610-2.

  PMID: 38252388 RESULT

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: July 25, 2019
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (1)