Evidence map›Paper›PMID 23613104›Full record

ArticleEuropean journal of nuclear medicine and molecular imaging2013

The clinical safety, biodistribution and internal radiation dosimetry of [¹⁸F]fluciclovine in healthy adult volunteers.

Brian J McParland, Anders Wall, Silvia Johansson, Jens Sørensen

Abstract read
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In one paragraph

Article in European journal of nuclear medicine and molecular imaging, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
1.9field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. [European journal of nuclear medicine and molecular imaging · 2020
    Guideline
  4. [European journal of nuclear medicine and molecular imaging · 2026
    Trial
  5. The Lancet. Oncology · 2019
    Trial
  6. Trial
  7. Review
  8. Review
  9. Review
  10. [EJNMMI research · 2020
    Article
  11. Article
  12. Human biodistribution and radiation dosimetry of [European journal of nuclear medicine and molecular imaging · 2020
    Article
  13. Review
  14. Review
  15. Update onJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2018
    Review
  16. SimultaneousFrontiers in oncology · 2018
    Article
  17. PET Tracers Beyond FDG in Prostate Cancer.Seminars in nuclear medicine · 2016
    Review
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 2 countries.

Brian J McParlandImaging Technology Group, GE Healthcare Medical Diagnostics, The Grove Centre, White Lion Road, Amersham, Buckinghamshire, UK HP7 9LL. brian.mcparland@ge.com
Anders Wall
Silvia Johansson
Jens Sørensen
Uppsala University · SEGeneral Electric (Spain) · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe report on the biodistribution and internal radiation dosimetry in humans of [(18)F]fluciclovine, a synthetic L-leucine analogue being investigated as a potential diagnostic biomarker for neoplasia.

methodsWhole-body positron emission tomography (PET) scans of 6 healthy volunteers were acquired at up to 16 time points up to about 5 h after a bolus administration of [(18)F]fluciclovine (153.8 ± 2.2 MBq). Venous blood samples were taken up to about 4 h post-injection from which (18)F activity concentrations in whole blood and plasma were measured. Urine was collected as voided up to 4 h post-injection, from which the excreted (18)F activity was measured. Absolute values of the (18)F activity contained in up to 11 source regions (brain, salivary glands, lung, heart, pancreas, spleen, liver, red bone marrow, kidneys, uterus and urinary bladder contents) were determined directly from quantitative analysis of the images. For each source region, the (18)F activity decay-corrected and normalised to that injected, as a function of time, was fit by an analytical function which was subsequently integrated to yield the cumulated activity normalised to the injected activity. These normalised cumulated activities were then used as input to the Organ Level INternal Dose Assessment/EXponential Modelling (OLINDA/EXM) package to calculate the internal radiation dosimetry of each subject following the Medical Internal Radiation Dose (MIRD) schema. An effective dose was then estimated for each subject.

results[(18)F]Fluciclovine was clinically well tolerated in this study. Very little (18)F was excreted with only a mean value of 3.3% present in the urine at about 4 h post-injection; no activity within the intestinal contents was noted. The highest mean initial uptakes were measured in the liver (13.8%), red bone marrow (11.1%) and lung (7.1%). The highest mean radiation absorbed doses per unit administered activity were received by the pancreas (102.2 μGy/MBq), the cardiac wall (51.7 μGy/MBq) and the uterine wall (44.6 μGy/MBq). The mean effective dose per unit administered activity was 22.1 μSv/MBq.

conclusionThe internal radiation dosimetry of [(18)F]fluciclovine appears acceptable for PET imaging.

Indexed as

AdultCarboxylic AcidsCyclobutanesFemaleHumansPositron-Emission TomographyRadiometryRadiopharmaceuticalsTissue DistributionCarboxylic AcidsCyclobutanesfluciclovine F-18Radiopharmaceuticals

Identifiers

PMID23613104
OpenAlexW2033210286

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.