Impact of Free Mobility on FDG Uptake in PET Scans (MOBITEP)

Impact of Free Mobility on FDG Uptake During a PET Scan: Randomized Controlled Non-inferiority Study

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Whole Body Imaging
• Intervention / Treatment: Behavioral: Mobility group

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.

• Study Type: Interventional
• Enrollment (Estimated): 284
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adeline FRAT; Phone Number: +33 0238229722; Email: adeline.frat@chu-orleans.fr

Study Locations

• France
  • Orléans, France, 45067
    • Recruiting
    • Centre Hospitalier Universitaire d'Orléans
    • Contact: Adeline FRAT; Phone Number: +33238229722; Email: adeline.frat@chu-orleans.fr
    • Principal Investigator: Adeline FRAT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobility group; Participant will benefit from the study procedure (free mobility after FDG injection)	Behavioral: Mobility group; Free mobility between FDG injection and scanning (without exiting the Nuclear Medicine Department)
No Intervention: Control group; participant will benefit from the standard examination procedure (rest after FDG injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: no muscular fixation (interpretable examination); some muscular fixations that do not interfere with medical interpretation (interpretable examination); 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.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical SUV max		Day 0
Lumbosacral SUV max		Day 0
Improving patient comfort	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Adeline FRAT, CHU Orléans

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: image quality; FDG PET; muscular uptake; Diagnostic Technics and Procedures
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CHUO-2024-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No