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

Cancer Clinical Trial

— IQversusMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956459
• Other study ID #: 19 GENE 03
• Status: Completed
• Phase: N/A
• Start date: July 25, 2019
• Est. completion date: February 4, 2021

Study information

• Verified date: February 2021
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 4, 2021
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years old.

2. A patient with a cancer for which a FDG-PET (fluorodeoxyglucose-positron emission tomography) must be performed according to the standard practices

3. OMS = 1, Karnofsky Index > 70.

4. Negative pregnancy test at inclusion.

5. Patient able to maintain a lying position in a strict supine position twice.

6. Patient affiliated to a Social Health Insurance in France.

7. Patient who has signed informed consent prior inclusion in the study and before any specific procedures for the study.

Exclusion Criteria:

1. Patient with unbalanced diabetic

2. Patient with a formal contraindication usual for certain imaging procedures (severe claustrophobia, wearing a heart valve, pacemaker, etc.)

3. Pregnant or breastfeeding woman

4. 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

5. Patient protected by law

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
France	Institut Universitaire du Cancer Toulouse - Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative rate of virtual lesions detected by each system ("Discovery MI" and "Discovery IQ")		24 hours for each patient
Secondary	Rate of Inter-observer concordance in radiological images interpretation		24 hours for each patient