臨床研究等提出・公開システム

Imaging correction methods for seated-type brain-dedicated PET

Brain PET correction

12

22 to 45 years old male healthy adult volunteers

The fist volunteer was conducted on June 4, 2021, and the 10th on September 3, 2021. Of these, 1 was excluded because part of the data could not be acquired due to data communication trouble. Then, the 11the volunteer was performed on September 10, 2021, but a space-occupying lesion was observed on MRI and then was excluded from the analysis. The 12th volunteer was conducted on December 17, 2021. Then, the total of 10 volunteers for analysis were completed.

No diseases were observed.

Primary endpoint 1)Motion correction method: The quality of images with the motion correction method should be better than that of images without it. Visual evaluation by two nuclear medicine physicians was performed. The concordance rate of the two rater was good (kappa=0.36-0.905), and the images with the correction were judged to be better in the overall evaluation with an average of 50%. As a result, the motion correction method was effective. 2)Attenuation correctio method: There should be no significantly difference in pixel values between the reference standard images and our developed PET images. Based on the statistical comparison, the differences were found in the mesial temporal and medial parietal area with 4% higher on average in our developed PET images than the reference standard. 3)Image evaluation method: The image quality evaluation index should reflect the image quality, which was degraded virtually. The index was well correlated with the image degradation, suggesting the index is useful to evaluate image quality. Secondary endpoint 1)Motion correction method: Statistically deference in the pixel value between the images with the motion correction and those without it. As a result, no significant difference was observed. 2) Amount of head movement: the amount of head movement during imaging using our developed PET. As a result, 5m 38 sec on average after the scan start, the head moved more than 2mm at the edge of the head. The largest direction of movement was pitch, which is like a nod direction.

This study addressed on three sections: 1) motion correction method, 2) attenuation method, and 3) objective evaluation method of image quality. As a results, 1) motion correction method was useful especially in visualization of gyri, 2) the data with brain-dedicated PET showed slightly higher voxel values in the mesial temporal and medial parietal area, and 3) the developed image-quality index correlated well with the degree of performance of the arbitrarily degraded PET detector.

Jan. 10, 2023

July. 19, 2022

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9515015/pdf/12149_2022_Article_1774.pdf

Yes

After publication of this study, de-identified (anonymized) or coded (pseudonymized) individual clinical trial participant data would be shared when needed, upon request from a third party including domestic, oversea researchers, doctors and company, authorized by the researchers sharing patents with ATOX CO., LTD.

https://jrct.mhlw.go.jp/latest-detail/jRCTs032210086

Takahashi Miwako

National Institutes for Quantum Science and Technology

4-9-1 Anagawa Inage-ku Chiba-shi Chiba, Japan

takahashi.miwako@qst.go.jp

Takahashi Miwako

National Institutes for Quantum Science and Technology

4-9-1 Anagawa Inage-ku Chiba-shi Chiba, Japan

+81-43-206-3260

takahashi.miwako@qst.go.jp

Complete

May. 13, 2021

Interventional

single arm study

single blind

active control

single assignment

diagnostic purpose

A healthy adult male who applies based on his own will and is judged to be able to understand the contents of the explanatory document.

1.Smoker or ex-smoker
2.Evidence of any medical treatment
3.History of central nervous system treatment
4.History of severe disease or surgery
5.Claustrophobia
6.Tattoos (including tattoos and permanent makeup), pacemakers, cochlear implants
7. Subjects who are judged by doctors to be inappropriate for research

Male

Epilepsy

Brain PET scan with seated-type brain dedicated PET (unapproved)

Improvement of image quality by image correction method.
Non-inferiority to conventional method.
Correlation between image quality evaluation value and device performance.

Statistical difference of images before and after correction.
Head movement amount.

+81-43-206-4706

April. 23, 2021

None