An interventional study of Mobility group in Neoplasms and Whole Body Imaging, sponsored by Centre Hospitalier Régional d'Orléans. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Other
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 284 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Centre Hospitalier Régional d'Orléans is the lead sponsor of 129 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Participant will benefit from the study procedure (free mobility after FDG injection)
Behavioral: Mobility group
participant will benefit from the standard examination procedure (rest after FDG injection)
Free mobility between FDG injection and scanning (without exiting the Nuclear Medicine Department)
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: 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.
Time frame: Day 0
Cervical SUV max
Time frame: Day 0
Lumbosacral SUV max
Time frame: Day 0
Improving patient comfort
Item-by-item comparisons are made between the two groups
Time frame: Day 0
Level of stress
Item-by-item comparisons are made between the two groups
Time frame: Day 0
Examination quality score
Factors that may influence the examination quality score will be analyzed.
Time frame: Day 0
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Régional d'Orléans