- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03956459
Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer (IQversusMI)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Toulouse, France
- Institut Universitaire du Cancer Toulouse - Oncopole
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patients with a cancer
|
For each patient, 2 consecutive PET-CT scanners will be performed using 2 different systems of PET-CT scanners:
Only one contrast agent injection (FDG) will be given for both scanners. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relative rate of virtual lesions detected by each system ("Discovery MI" and "Discovery IQ")
Time Frame: 24 hours for each patient
|
24 hours for each patient
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of Inter-observer concordance in radiological images interpretation
Time Frame: 24 hours for each patient
|
24 hours for each patient
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19 GENE 03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on Patients with a cancer for which a FDG-PET scanner must be performed
-
Assistance Publique - Hôpitaux de ParisUnknownCancer | Venous Thromboembolism
-
Sidekick HealthLandspitali University Hospital; Ljósið Cancer Rehabilitation CenterActive, not recruiting
-
Ohio State University Comprehensive Cancer CenterCompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Federal State Budgetary Scientific Institution...CompletedPrevention of Diseases of the Musculoskeletal SystemRussian Federation
-
Sidekick HealthLandspitali University Hospital; Ljósið Cancer Rehabilitation CenterActive, not recruitingCancer | Colorectal Cancer | Lung Cancer | Prostate CancerIceland
-
Irish Research Radiation Oncology GroupRecruiting
-
Memorial Sloan Kettering Cancer CenterCompletedRectal CancerUnited States
-
Memorial Sloan Kettering Cancer CenterCompletedThyroid Cancer | Papillary MicrocarcinomaUnited States
-
Assiut UniversityNot yet recruitingLocally Advanced Cervical Carcinoma
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)Completed