Study to Develop a Kinetic Model for FDG and Me4FDG in Kidneys of Type 2 Diabetic Patients

NCT03557138 | Unknown

• 1 other identifier: 1128/2016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, using 18F-FDG and Gd-DTPA PET/MRI, we are aiming to perform a dynamic PET/MRI imaging using 18F-FDG and Me4FDG for a group of type 2 diabetic patients scheduled for Glifozine therapy due to the bad metabolic control to assess changes in renal function before and 1 to 2 weeks after initiating therapy with Gliflozine. Furthermore we aim to study the temporal behavior of 18F-FDG and Me4FDG activity in certain kidney regions of the diabetic participants to estimate basic kidney parameters using time activity curve. Further, we intend to find a kinetic model that describes the behavior of glucose in each part of the kidney can be acquired mathematically and to find out whether conclusions about the glucose reabsorption capability of the kidney in diabetes can be achieved in general. In addition, we aim to simultaneously determine renal lesions as well as obstructions with the fused, high definition, and three dimensional images of the kidney and estimate kidney function parameters from the dynamic Gd-DTPA MRI scan and compare them to the kidney function determined with the kinetic model.

Conditions

Type2 Diabetes Mellitus

Keywords

SGLT2 inhibitor; 18F-FDG; alpha-Methyl-4-18F-FDG

Outcome Measures

Primary Outcomes (1)

• Kinetic behavior of glucose reabsorption

  mathematically acquire a kinetic model of glucose reabsorption capability in each part of the kidney in type 2 diabetic patient under SGLT2-inhibitor therapies.

  one year

Secondary Outcomes (1)

• positron emission tomography (PET)

  one year

Study Arms (1)

Me4FDG

EXPERIMENTAL

Intravenous injection of alpha-Methyl-4-deoxy-4-\[(18)F\]fluoro-D-glucopyranoside (Me4FDG) and FDG for evaluation the kidney kinetic model of FDG and Me4FDG in type 2 diabetic patients with SGLT2-inhibitor therapies.

Behavioral: alpha-Methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside

Interventions

alpha-Methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside BEHAVIORAL

positron emission tomography and magnetic resonance imaging (PET/MRI) of kidneys of diabetic patients using alpha-Methyl-4-deoxy-4-\[(18)F\]fluoro-D-glucopyranoside (Me4FDG)

Me4FDG

Eligibility Criteria

• Age: 18 Years - 74 Years
• Gender Eligibility Details: male and female diabetic patients with SGLT2-inhibitor therapies
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 DM.
• Aged 20 -74 years.
• HbA1c level \> 7%.
• Planned initiation of Gliflozine treatment.
• Intact renal function (serum creatinine \< 1.5mg/dl or urinary albumin:creatinine ratio \< 300mg/g in random urine sample).
• Written informed consent.

You may not qualify if:

• Age \< 18 years, as kidneys may not be fully developed and not working properly yet.
• Impaired renal function (serum creatinine ≥ 1.5mg/dl or urinary albumin:creatinine ratio \> 300mg/g in random urine sample) as well as anatomically altered or harmed kidneys could falsify the results due to their different or high alterable time activity curves.
• Patients under corticosteroids and diuretics therapies.
• MR-unsafe implants such as pacemakers and implantable cardioverter-defibrillators
• Intolerance of MRI contrast agents.
• Claustrophobia.
• Patients, who are not able to lie still without changing position for a minimum of 30 minutes.
• Pregnancy.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Radiology and Nuklear Medicine

Vienna, 1090, Austria

RECRUITING

Related Publications (4)

• Kobayashi M, Shikano N, Nishii R, Kiyono Y, Araki H, Nishi K, Oh M, Okudaira H, Ogura M, Yoshimoto M, Okazawa H, Fujibayashi Y, Kawai K. Comparison of the transcellular transport of FDG and D-glucose by the kidney epithelial cell line, LLC-PK1. Nucl Med Commun. 2010 Feb;31(2):141-6. doi: 10.1097/MNM.0b013e328333bcf5.

  PMID: 19949354 BACKGROUND

• Geist BK, Baltzer P, Fueger B, Hamboeck M, Nakuz T, Papp L, Rasul S, Sundar LKS, Hacker M, Staudenherz A. Assessing the kidney function parameters glomerular filtration rate and effective renal plasma flow with dynamic FDG-PET/MRI in healthy subjects. EJNMMI Res. 2018 May 9;8(1):37. doi: 10.1186/s13550-018-0389-1.

  PMID: 29744748 BACKGROUND

• Geist BK, Ramirez JC, Binder P, Einspieler H, Ibeschitz H, Langsteger W, Nics L, Rausch I, Diemling M, Sohlberg A, Hacker M, Rasul S. In vivo assessment of safety, biodistribution, and radiation dosimetry of the [18F]Me4FDG PET-radiotracer in adults. EJNMMI Res. 2024 May 15;14(1):46. doi: 10.1186/s13550-024-01098-2.

  PMID: 38750398 DERIVED

• Rasul S, Geist BK, Brath H, Baltzer P, Sundar LKS, Pichler V, Mitterhauser M, Kautzky-Willer A, Hacker M. Response evaluation of SGLT2 inhibitor therapy in patients with type 2 diabetes mellitus using 18F-FDG PET/MRI. BMJ Open Diabetes Res Care. 2020 Mar;8(1):e001135. doi: 10.1136/bmjdrc-2019-001135.

  PMID: 32205328 DERIVED

MeSH Terms

Interventions

methyl-4-fluoro-4-deoxyglucose

Study Officials

• Marcus Hacker, Prof., MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus Hacker, Prof., MD

CONTACT

+43 14040055310; marcus.hacker@meduniwien.ac.at

Sazan Rasul, MD, PHD

CONTACT

+43 14040055480; sazan.rasul@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 14, 2018
• Study Start: February 22, 2017
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

AU (1)