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

Centre Hospitalier Régional d'Orléans

Status: Enrolling

Conditions: Neoplasms; Whole Body Imaging

Treatments: Behavioral: Mobility group

Study type: Interventional

Funder types: Other

Identifiers

NCT06799819

CHUO-2024-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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284 participants in 2 patient groups

Mobility group

Experimental group

Description:

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

Treatment:

Behavioral: Mobility group

Control group

No Intervention group

Description:

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