Neoplasms, Whole Body Imaging
Conditions
Keywords
FDG PET, muscular uptake, image quality, Diagnostic Technics and Procedures
Brief summary
Positron Emission Tomography (PET) is a rather long examination (around 2 hours), involving an injection of 18F-Fluorodeoxyglucose (FDG), which requires the patient to rest for 1 hour between the injection and the start of imaging. Some hospitals allow the patient to sit, read or use the telephone, but none allow the patient to move freely after injection, hence the interest of this work. The aim of this study is to demonstrate that free mobilization of the patient following 18F-FDG injection does not result in any significant difference in imaging quality (particularly muscular fixations), and therefore a medical interpretation identical to that of a patient who remains at rest.
Detailed description
FDG-PET is a fairly long scan involving an injection of 18F-FDG. Because of the fear of muscular fixations, the guidelines recommend for rest between injection and image acquisition. Indeed, some studies have demonstrated significant muscular uptake of the radiopharmaceutical in the event of major muscular effort prior to the examination. However, to investigators knowledge, the effect of free mobilization between injection and scan has not been evaluated. The aim of this study is to demonstrate that free mobilization of the participant after 18F-FDG injection does not result in a significant difference in imaging quality (especially muscular fixation) and therefore in a medical interpretation identical to that of a patient who remains at rest. Investigators also want to assess the impact on participant comfort and stress. Each participant will receive an information leaflet with his or her examination appointment. On arrival in the department, after the study has been explained by the investigator and the participant has had all his questions answered, participant may accept inclusion by signing a consent form or refuse it. Once the inclusion of the participant has been validated, the randomisation will be done: the control group will benefit from the standard examination procedure (rest after FDG injection) and the experimental group will benefit from the study procedure (free mobility after FDG injection). The participant will complete a questionnaire on level of stress and comfort after the imaging procedure, and the nuclear physician will provide a blind interpretation. A review of all blinded examinations will be carried out by two nuclear physicians to establish an examination quality score. An intermediate analysis will be carried out when 50% of exclusions have been reached to stop the study if the management studied is detrimental compared with standard management.
Interventions
BEHAVIORALMobility group
Free mobility between FDG injection and scanning (without exiting the Nuclear Medicine Department)
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Blind analysis of the imaging
Intervention model description
Prospective, randomized, controlled, comparative, single-center, non-inferiority and single-blind (for the evaluator) study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults 2. Patient referred for FDG PET (excluding brain PET) and carried out on an outpatient basis.
Exclusion criteria
1. Bedridden patients 2. Protected person (under guardianship or curatorship) 3. Persons under court protection 4. Persons deprived of liberty 5. Persons not affiliated to a social security scheme 6. Pregnant or breast-feeding woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual image quality score (in terms of muscle fixations) | Day 0 | The visual quality of the images will be the main evaluation criterion. An overall examination quality score will be given by the investigator for each patient, using a 3-point Likert scale: 1. no muscular fixation (interpretable examination) 2. some muscular fixations that do not interfere with medical interpretation (interpretable examination) 3. significant muscular fixations that make the examination uninterpretable. The main evaluation criterion will be the proportion of score 1 in the two groups of patients (with and without strict rest), bearing in mind that images scored 3 are very rare. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervical SUV max | Day 0 | — |
| Lumbosacral SUV max | Day 0 | — |
| Improving patient comfort | Day 0 | Item-by-item comparisons are made between the two groups |
| Level of stress | Day 0 | Item-by-item comparisons are made between the two groups |
| Examination quality score | Day 0 | Factors that may influence the examination quality score will be analyzed. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAdeline FRAT
CHU Orléans
Outcome results
None listed