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NeoplasmsMOBITEPNCT06799819

Impact of Free Mobility on FDG Uptake in PET Scans

A study testing Mobility group in people with Neoplasms and Whole Body Imaging, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Whole Body Imaging
What is being tested?
Mobility group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
284 participants
Where
1 siteFrance
Study dates
30 Apr 2025to 15 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults
  • Patient referred for FDG PET (excluding brain PET) and carried out on an outpatient basis.

Who cannot join

  • Bedridden patients
  • Protected person (under guardianship or curatorship)
  • Persons under court protection
  • Persons deprived of liberty
  • Persons not affiliated to a social security scheme
  • Pregnant or breast-feeding woman

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier Universitaire d'Orléans

    Orléans, 45067

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Mobility group
Keywords
FDG PET, muscular uptake, image quality, Diagnostic Technics and Procedures
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobility groupBehavioural

    Free mobility between FDG injection and scanning (without exiting the Nuclear Medicine Department)

Study groups in NCT06799819
Study groupRoleWhat they receive
Mobility groupExperimentalParticipant will benefit from the study procedure (free mobility after FDG injection)
Receives: Behavioral: Mobility group
Control groupNo interventionparticipant will benefit from the standard examination procedure (rest after FDG injection)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 0

Secondary outcomes (5)

  1. Cervical SUV max

    Measured: Day 0

  2. Lumbosacral SUV max

    Measured: Day 0

  3. Improving patient comfort

    Item-by-item comparisons are made between the two groups

    Measured: Day 0

  4. Level of stress

    Item-by-item comparisons are made between the two groups

    Measured: Day 0

  5. Examination quality score

    Factors that may influence the examination quality score will be analyzed.

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2025
  2. Study start30 Apr 2025
  3. Primary completion15 Jun 2026
  4. Study completion15 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, controlled, comparative, single-center, non-inferiority and single-blind (for the evaluator) study.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06799819
Sponsor's protocol ID
CHUO-2024-16
Acronym
MOBITEP
Status last verified
Jun 2026
First submitted
21 Jan 2025
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 19223428

  • 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.

    PubMed 26001118

  • 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.

    PubMed 9935060

  • 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.

    PubMed 36928161

  • 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.

    PubMed 28368886

  • 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.

    PubMed 17242567

Questions about this trial

What is this clinical trial studying?

A study testing Mobility group in people with Neoplasms and Whole Body Imaging, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual image quality score (in terms of muscle fixations) (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06799819, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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