Clinical trial NCT06799819: Impact of Free Mobility on FDG Uptake in PET Scans
Official title: Impact of Free Mobility on FDG Uptake During a PET Scan: Randomized Controlled Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Whole Body Imaging
Keywords: FDG PET
muscular uptake
image quality
Diagnostic Technics and Procedures
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled, comparative, single-center, non-inferiority and single-blind (for the evaluator) study.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual image quality score (in terms of muscle fixations)
timeFrame: Day 0
Secondary outcomes:
measure: Cervical SUV max
timeFrame: Day 0
measure: Lumbosacral SUV max
timeFrame: Day 0
measure: Improving patient comfort
timeFrame: Day 0
measure: Level of stress
timeFrame: Day 0
measure: Examination quality score
timeFrame: Day 0
Other outcomes:
Locations:
city: Orléans
country: France
facility: Centre Hospitalier Universitaire d'Orléans
Study officials:
affiliation: CHU Orléans
name: Adeline FRAT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.