Renal 15O-gas PET

JRCT ID: jRCT1052220158

Registered date:30/01/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients with renal artery stenosis, diabetic nephropathy, and nephrosclerosis
• Date of first enrollment: 30/01/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Using the 15O-gas rapid analysis system, PET images are generated by inhalaing O15 gas to obtain PET images for renal blood flow, renal blood volume, renal oxygen metabolism, and renal oxygen consumption.

Outcome(s)

Primary Outcome

Main Outcomes
Calculation of qualitative indices (tissue blood flow, oxygen metabolism, oxygen uptake rate) in nuclear medicine examinations in the targeted diseases

Secondary Outcome

Secondary outcomes
1) Relationship between treatment administered and blood/urine data in the targeted diseases
2) Relationship of renal cortex, renal medulla, renal goblet. to other imaging information such as CT, ultrasonography. in the above target diseases on images
3) Quantitative values of a) Regional renal blood flow (RBF) b) Regional renal oxygen consumption (RMRO2 c) Renal blood volume (RBV) and blood cell distribution and evaluation of glomerular function d) Quantitative values of regional oxygen uptake fraction (OEF) and reabsorption capacity of medullary region
4) Relationship between the urinary biomarkers Liver-type Fatty Acid-Binding Protein (L-FABP) and Adrenomedullin (AM) and the above RBF, RMRO2, RBV and OEF
5) Quantification of vascular reserve images and calculation of SUV and other quantitative indices

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients with renal artery stenosis, diabetic nephropathy, or nephrosclerosis who are admitted to the Division of Nephrology and Hypertension at the National Cardiovascular Center for the purpose of medical treatment or catheter intervention
(2) Adult patients 20 years of age or older
(3) Patients who can obtain written consent from the patient.

Exclude criteria

(1) Patients inappropriate as research subjects by the research physician
(2) Patients of Dialysis, nephrotic syndrome, chronic glomerulonephritis, ANCA-related vasculitis, chronic interstitial glomerulonephritis, acute kidney injury
(3) Patients participating in other clinical trials (except for observational studies)

Related Information

• Primary Sponsor: Fukuda Tetsuya
• Source(s) of Monetary Support: Tosoh Corporation