Impact of Free Mobility on FDG Uptake in PET Scans

NCT06799819 | Recruiting DMC

• 1 other identifier: CHUO-2024-16
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Whole Body Imaging

Keywords

FDG PET; muscular uptake; image quality; Diagnostic Technics and Procedures

Outcome Measures

Primary Outcomes (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.

  Day 0

Secondary Outcomes (5)

• Cervical SUV max

  Day 0

• Lumbosacral SUV max

  Day 0

• Improving patient comfort

  Day 0

• Level of stress

  Day 0

• Examination quality score

  Day 0

Study Arms (2)

Mobility group

EXPERIMENTAL

Participant will benefit from the study procedure (free mobility after FDG injection)

Behavioral: Mobility group

Control group

NO INTERVENTION

participant will benefit from the standard examination procedure (rest after FDG injection)

Interventions

Mobility group BEHAVIORAL

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

Mobility group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Centre Hospitalier Universitaire d'Orléans

Orléans, 45067, France

RECRUITING

Related Publications (6)

• 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.

  PMID: 19223428 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.

  PMID: 26001118 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.

  PMID: 9935060 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.

  PMID: 36928161 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.

  PMID: 28368886 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.

  PMID: 17242567 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Adeline FRAT

  CHU Orléans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeline FRAT

CONTACT

0238229722; adeline.frat@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blind analysis of the imaging
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, comparative, single-center, non-inferiority and single-blind (for the evaluator) study.

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 29, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

FR (1)