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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobility group | Experimental | Participant will benefit from the study procedure (free mobility after FDG injection) |
|
| Control group | No Intervention | participant will benefit from the standard examination procedure (rest after FDG injection) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobility group | Behavioral | Free mobility between FDG injection and scanning (without exiting the Nuclear Medicine Department) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual image quality score (in terms of muscle fixations) | 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:
| Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical SUV max | Day 0 | |
| Lumbosacral SUV max | Day 0 | |
| Improving patient comfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adeline FRAT | CHU Orléans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire d'Orléans | Orléans | 45067 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19223428 | Background | Reinking MF, Osman MM. Prospective evaluation of physiologic uptake detected with true whole-body 18F-FDG PET/CT in healthy subjects. J Nucl Med Technol. 2009 Mar;37(1):31-7. doi: 10.2967/jnmt.108.055004. Epub 2009 Feb 17. | |
| 26001118 | Background | Karunanithi S, Soundararajan R, Sharma P, Naswa N, Bal C, Kumar R. Spectrum of Physiologic and Pathologic Skeletal Muscle (18)F-FDG Uptake on PET/CT. AJR Am J Roentgenol. 2015 Aug;205(2):W141-9. doi: 10.2214/AJR.14.13457. Epub 2015 May 22. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Prospective, randomized, controlled, comparative, single-center, non-inferiority and single-blind (for the evaluator) study.
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Blind analysis of the imaging
Item-by-item comparisons are made between the two groups
| Day 0 |
| Level of stress | Item-by-item comparisons are made between the two groups | Day 0 |
| Examination quality score | Factors that may influence the examination quality score will be analyzed. | Day 0 |
| 9935060 | Background | Tashiro M, Fujimoto T, Itoh M, Kubota K, Fujiwara T, Miyake M, Watanuki S, Horikawa E, Sasaki H, Ido T. 18F-FDG PET imaging of muscle activity in runners. J Nucl Med. 1999 Jan;40(1):70-6. |
| 36928161 | Background | Okuyama C, Kusano K, Ito M, Takase A, Goda S, Kagawa S. Characteristic Muscular FDG Uptake Patterns Related to the Transportation Means Used by Patients to Visit the Hospital. Clin Nucl Med. 2023 Jun 1;48(6):549-552. doi: 10.1097/RLU.0000000000004622. Epub 2023 Mar 16. |
| 28368886 | Background | Wang Y, Shao F, Zhang L, Luo X, Chen Y. Increased 18F-FDG Uptake in Multiple Muscles in a Patient With Violent Cough. Clin Nucl Med. 2017 Jun;42(6):451-453. doi: 10.1097/RLU.0000000000001655. |
| 17242567 | Background | Vock J, Juengling FD, Krause T, Wissmeyer M. Muscular FDG uptake after chewing chewing gum in a patient with Hodgkin disease. Clin Nucl Med. 2007 Feb;32(2):124-7. doi: 10.1097/01.rlu.0000252337.14196.ed. No abstract available. |