Embolism venous Neoplasm malignant MedDRA version: 21.1 Level: PT Classification code 10028997 Term: Neoplasm malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10014522 Term: Embolism venous System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: FLUDESOXYGLUCOSE (18F)-CURIUM
Product Name: Fludesoxyglucose (18F)
Pharmaceutical Form: Injection
Sponsors
CHRU de Brest
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 50 years or older with a new diagnosis of first unprovoked proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) as detailed below will be eligible to participate into the study. -No recent (less than 3 months) paralysis, paresis, or plaster immobilization of lower extremities; - No major surgery (within the past 3 months) requiring general or regional anaesthesia; - No known thrombophilia; - No active malignancy (known malignancy, progressive and/or treated during the last 5 years) except for adequately treated basal or squamous cell carcinoma Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 238 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they have any of the following criteria: 1) Hypersensitivity to 18F-FDG or any of the excipients according to the product monograph; 2) Unavailable to follow-up; 3) VTE while on anticoagulation (e.g apixaban, rivaroxaban, edoxaban, dabigatran, warfarin) 4) VTE provoked by a major inherited or acquired risk factor; 5) Refusal or inability to provide informed consent; 6) Life expectancy <12 months; 7) Ongoing pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether adding a FDG-PET/CT to a limited screening strategy misses less cancer than a limited cancer screening strategy alone in patients aged 50 years or older with a first unprovoked VTE over a 1-year follow-up period. ;Secondary Objective: 1) To compare the proportion of patients receiving a cancer diagnosis at the initial allocated screening strategy. 2) To assess whether the extensive screening strategy including FDG PET/ CT enables the diagnosis of more early-stage cancers than the limited screening strategy. 3) To find out if the patients diagnosed with cancer are still alive after five years (i.e. the patients with curable cancer were treated and are doing well). 4) To assess the cost and the effectiveness (cancers detected) of adding FDG-PET/CT to limited screening in patients with unprovoked VTE. 5) To compare the frequency of patients receiving additional tests following each strategy at screening and during follow-up. 6) To develop a decision aid to assist patients in the decision of cancer screening. ;Primary end point(s): Occult cancer “missed” by cancer screening defined as proven cancer diagnosed (either biopsy proven cancer or cancer diagnosis approved by adjudication committee in the absence of biopsy proven cancer) from the time of cancer screening completion to the end of the 1-year follow-up period, and not detected at the time of screening. In other words, “missed” means the number of new cancers diagnosed in patients considered not to have cancer after having completed the assigned cancer screening strategy (i.e false negative results of screening strategies). An independent Central Adjudication Committee has been assembled and will blindly adjudicate all study outcomes near the completion of the trial;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) New cancer diagnosis after completion of the initial allocated screening strategy. 2) Early-stage (T1-2N0M0 as per the World Health Organization TNM classification system) and advanced-stage tumors at initial screening and during follow-up. 3) Cancer-related mortality during a 5-year follow-up period. 4) Diagnosis of cancer and costs from the viewpoint of the healthcare system over a one-year period in order to estimate the additional cost per additional cancer detected 5) Additional tests following each strategy and during follow-up. 6) The data of this study will be used to develop a decision aid to assist future patients in the decision of cancer screening ;Timepoint(s) of evaluation of this end point: 5 years | — |
Countries
Canada, France
Contacts
Public ContactMORVAN
CHRU de Brest
Outcome results
None listed