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In vivo assessment of safety, biodistribution, and radiation dosimetry of the [ 18 F]Me4FDG PET-radiotracer in adults.
- Source :
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EJNMMI research [EJNMMI Res] 2024 May 15; Vol. 14 (1), pp. 46. Date of Electronic Publication: 2024 May 15. - Publication Year :
- 2024
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Abstract
- Background: Approaches targeting the sodium-glucose cotransporter (SGLT) could represent a promising future therapeutic strategy for numerous oncological and metabolic diseases. In this study, we evaluated the safety, biodistribution and radiation dosimetry of the glucose analogue positron emission tomography (PET) agent [ <superscript>18</superscript> F] labeled alpha-methyl-4-deoxy-4-[ <superscript>18</superscript> F]fluoro-D-glucopyranoside ([ <superscript>18</superscript> F]Me4FDG) with high sodium-glucose cotransporter and low glucose transporter (GLUT) affinity. For this purpose, five healthy volunteers (1 man, 4 women) underwent multiple whole-body PET/computed tomography (CT) examinations starting with injection and up to 4 h after injection of averaged (2.4 ± 0.1) MBq/kg (range: 2.3-2.5 MBq/kg) administered activity. The PET/CT scans were conducted in 5 separate sessions, blood pressure and temperature were measured, and blood and urine samples were collected before the scans and one hour after injection to assess toxicity. Measurements of [ <superscript>18</superscript> F]Me4FDG radioactivity in organs of interest were determined from the PET/CT scans at 5 time points. Internal dosimetry was performed on voxel level using a fast Monte Carlo approach.<br />Results: All studied volunteers could well tolerate the [ <superscript>18</superscript> F]Me4FDG and no adverse event was reported. The calculated effective dose was (0.013 ± 0.003) mSv/MBq. The organs with the highest absorbed dose were the kidneys with 0.05 mSv/MBq per kidney. The brain showed almost no uptake. After 60 min, (12 ± 15) % of the administered dose was excreted into the bladder.<br />Conclusion: Featuring an effective dose of only 0.013 ± 0.003 mSv/MBq and no occurrence of side effects, the glucose analogue [ <superscript>18</superscript> F]Me4FDG seems to be a safe radio-tracer with a favorable biodistribution for PET imaging and also within several consecutive scans.<br />Trial Registration Number: NCT03557138, Registered 22 February 2017, https://ichgcp.net/clinical-trials-registry/NCT03557138 .<br /> (© 2024. The Author(s).)
Details
- Language :
- English
- ISSN :
- 2191-219X
- Volume :
- 14
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- EJNMMI research
- Publication Type :
- Academic Journal
- Accession number :
- 38750398
- Full Text :
- https://doi.org/10.1186/s13550-024-01098-2