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

NCT ID: NCT03956459

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-25

Study Completion Date

2021-02-04

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with a cancer

Group Type OTHER

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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Claudius Regaud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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19 GENE 03

Identifier Type: -

Identifier Source: org_study_id

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