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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05779865
Other study ID # 23-04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2023
Est. completion date September 21, 2023

Study information

Verified date September 2023
Source Centre Hospitalier Princesse Grace
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Lesions blurred by respiratory motion are common in fluorine-18 PET/CT studies. To avoid these artefacts, several standard gating correction technics are available. the investigator aimed to compare the impact of different gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device on standardized uptake value (SUVmax and SUVpeak) and uptake volume (UV) measurements on different sizes of pulmonary and liver lesions. The feasability of this study will be done using anthropomorphic coupled with a motion phantom and on a series of patients.


Description:

PET-CT images will be acquired on a Biograph Vision600 PET/CT, fitted with 26cm axial field of view and time of flight. Phantom study will use an anthropomorphic TORSO phantom with a programmable motion phantom, mimicking respiratory motion (QUASAR). Spheres with various internal diameters will be introduce into the lungs (air density) adding an axial mechanical device simulating breathing movement of +/-20mm. Concentration in the spheres will be the same for all diameters. The background and liver activities will be approximatively respectively 38 and 14 MBq. This phantom will be a simulating patient only for lung lesions. The investigator will compare 6 different PET acquisitions: standard 3min acquisition without movement as our reference of "trues SUVmax and UV", 3min acquisition with simulated breathing movement without any gating and 3min with respectively gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device. Patient study will be on 50 consecutive patients with lung or liver nodules. 18F-FDG injection will be around 2.5 MBq/kg. The investigator will compare 5 different PET acquisitions: standard acquisition with free respiratory movement as our reference of "trues SUVmax and UV", acquisitions with respectively gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date September 21, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - presence at least of one hepatic or lung nodule Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Monaco Centre Hospitalier Princesse Grace Monaco

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Princesse Grace

Country where clinical trial is conducted

Monaco, 

References & Publications (2)

Meier JG, Wu CC, Betancourt Cuellar SL, Truong MT, Erasmus JR, Einstein S, Mawlawi O. Evaluation of a novel elastic respiratory motion correction algorithm on quantification and image quality in abdomino-thoracic PET/CT. J Nucl Med. 2018 Aug 16;60(2):279-284. doi: 10.2967/jnumed.118.213884. Online ahead of print. — View Citation

Soret M, Bacharach SL, Buvat I. Partial-volume effect in PET tumor imaging. J Nucl Med. 2007 Jun;48(6):932-45. doi: 10.2967/jnumed.106.035774. Epub 2007 May 15. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of the different gating systems in lung lesions visualization Classification, based on a phantom and patients studies, of the different gating system in view of the volume and SUV (max and peak) modification for lung lesions Inclusion
Secondary Comparison of the different gating systems in liver lesions visualization Classification, based on a patients studies, of the different gating system in view of the volume and SUV (max and peak) modification for liver lesions Inclusion
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