A Simple Kit for the Good-Manufacturing-Practice Production of [68Ga]Ga-EDTA

Monika Skulska; Lise Falborg

doi:10.3390/molecules28166131

A Simple Kit for the Good-Manufacturing-Practice Production of [68Ga]Ga-EDTA

Department of Clinical Medicine - Nuklearmedicin, RHG

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

1 Citation (Scopus)

Abstract

Glomerular filtration rates for individual kidneys can be measured semi-quantitatively by a gamma camera using [99mTc]Tc-DTPA, with limited diagnostic accuracy. A more precise measurement can be performed on a PET/CT scanner using the radiotracer [68Ga]Ga-EDTA, which has been validated in animal studies. The purpose of this study was to develop an easy kit-based synthesis of [68Ga]Ga-EDTA that is compliant with good manufacturing practice (GMP) and applicable for human use. The production of the cold kit and its labeling were validated, as were the radiochemical purity measurement and analytical procedures for determining the Na2EDTA dihydrate content in the kits. In this study, we validated a GMP kit for the simple production of [68Ga]Ga-EDTA, with the intention of applicability for human use.

Original language	English
Article number	6131
Journal	Molecules (Basel, Switzerland)
Volume	28
Issue	16
ISSN	1420-3049
DOIs	https://doi.org/10.3390/molecules28166131
Publication status	Published - 18 Aug 2023

Keywords

Animals
Edetic Acid
Gallium Radioisotopes
Glomerular Filtration Rate
Humans
Kidney
Positron Emission Tomography Computed Tomography

Access to Document

10.3390/molecules28166131

Cite this

@article{f5fa9c5509274314a4e059fd9f391c04,

title = "A Simple Kit for the Good-Manufacturing-Practice Production of [68Ga]Ga-EDTA",

abstract = "Glomerular filtration rates for individual kidneys can be measured semi-quantitatively by a gamma camera using [99mTc]Tc-DTPA, with limited diagnostic accuracy. A more precise measurement can be performed on a PET/CT scanner using the radiotracer [68Ga]Ga-EDTA, which has been validated in animal studies. The purpose of this study was to develop an easy kit-based synthesis of [68Ga]Ga-EDTA that is compliant with good manufacturing practice (GMP) and applicable for human use. The production of the cold kit and its labeling were validated, as were the radiochemical purity measurement and analytical procedures for determining the Na2EDTA dihydrate content in the kits. In this study, we validated a GMP kit for the simple production of [68Ga]Ga-EDTA, with the intention of applicability for human use.",

keywords = "Animals, Edetic Acid, Gallium Radioisotopes, Glomerular Filtration Rate, Humans, Kidney, Positron Emission Tomography Computed Tomography",

author = "Monika Skulska and Lise Falborg",

year = "2023",

month = aug,

day = "18",

doi = "10.3390/molecules28166131",

language = "English",

volume = "28",

journal = "Molecules (Basel, Switzerland)",

issn = "1420-3049",

publisher = "M D P I AG",

number = "16",

}

TY - JOUR

T1 - A Simple Kit for the Good-Manufacturing-Practice Production of [68Ga]Ga-EDTA

AU - Skulska, Monika

AU - Falborg, Lise

PY - 2023/8/18

Y1 - 2023/8/18

N2 - Glomerular filtration rates for individual kidneys can be measured semi-quantitatively by a gamma camera using [99mTc]Tc-DTPA, with limited diagnostic accuracy. A more precise measurement can be performed on a PET/CT scanner using the radiotracer [68Ga]Ga-EDTA, which has been validated in animal studies. The purpose of this study was to develop an easy kit-based synthesis of [68Ga]Ga-EDTA that is compliant with good manufacturing practice (GMP) and applicable for human use. The production of the cold kit and its labeling were validated, as were the radiochemical purity measurement and analytical procedures for determining the Na2EDTA dihydrate content in the kits. In this study, we validated a GMP kit for the simple production of [68Ga]Ga-EDTA, with the intention of applicability for human use.

AB - Glomerular filtration rates for individual kidneys can be measured semi-quantitatively by a gamma camera using [99mTc]Tc-DTPA, with limited diagnostic accuracy. A more precise measurement can be performed on a PET/CT scanner using the radiotracer [68Ga]Ga-EDTA, which has been validated in animal studies. The purpose of this study was to develop an easy kit-based synthesis of [68Ga]Ga-EDTA that is compliant with good manufacturing practice (GMP) and applicable for human use. The production of the cold kit and its labeling were validated, as were the radiochemical purity measurement and analytical procedures for determining the Na2EDTA dihydrate content in the kits. In this study, we validated a GMP kit for the simple production of [68Ga]Ga-EDTA, with the intention of applicability for human use.

KW - Animals

KW - Edetic Acid

KW - Gallium Radioisotopes

KW - Glomerular Filtration Rate

KW - Humans

KW - Kidney

KW - Positron Emission Tomography Computed Tomography

UR - http://www.scopus.com/inward/record.url?scp=85168756043&partnerID=8YFLogxK

U2 - 10.3390/molecules28166131

DO - 10.3390/molecules28166131

M3 - Journal article

C2 - 37630382

SN - 1420-3049

VL - 28

JO - Molecules (Basel, Switzerland)

JF - Molecules (Basel, Switzerland)

IS - 16

M1 - 6131

ER -

A Simple Kit for the Good-Manufacturing-Practice Production of [68Ga]Ga-EDTA

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

Cite this