title: Clinical Trial with Sodium99mTc-Pertechnetate Produced by a Medium-Energy Cyclotron: Biodistribution and Safety Assessment in Patients with Abnormal Thyroid Function.
abstract: A single-site prospective open-label clinical study with cyclotron-produced sodium99mTc-pertechnetate (99mTc-NaTcO4) was performed in patients with indications for a thyroid scan to demonstrate the clinical safety and diagnostic efficacy of the drug and to confirm its equivalence with conventional99mTc-NaTcO4eluted from a generator.Methods:99mTc-NaTcO4was produced from enriched100Mo (99.815%) with a cyclotron (24 MeV; 2 h of irradiation) or supplied by a commercial manufacturer (bulk vial eluted from a generator). Eleven patients received 325 ± 29 (mean ± SD) MBq of the cyclotron-produced99mTc-NaTcO4, whereas the age- and sex-matched controls received a comparable amount of the generator-derived tracer. Whole-body and thyroid planar images were obtained for each participant. In addition to the standard-energy window (140.5 keV ± 7.5%), data were acquired in lower-energy (117 keV ± 10%) and higher-energy (170 keV ± 10%) windows. Vital signs and hematologic and biochemical parameters were monitored before and after tracer administration.Results:Cyclotron-produced99mTc-NaTcO4showed organ and whole-body distributions identical to those of conventional99mTc-NaTcO4and was well tolerated. All images led to a clear final diagnosis. The fact that the number of counts in the higher-energy window was significantly higher for cyclotron-produced99mTc-NaTcO4did not influence image quality in the standard-energy window. Image definition in the standard-energy window with cyclotron-produced99mTc was equivalent to that with generator-eluted99mTc and had no particular features allowing discrimination between the99mTc production methods.Conclusion:The systemic distribution, clinical safety, and imaging efficacy of cyclotron-produced99mTc-NaTcO4in humans provide supporting evidence for the use of this tracer as an equivalent for generator-eluted99mTc-NaTcO4in routine clinical practice.
authors.affiliation: Sherbrooke Molecular Imaging Center, CRCHUS, Sherbrooke, Quebec, Canada Svetlana.V.Selivanova@USherbrooke.ca.|Department of Nuclear Medicine and Radiobiology, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, Quebec, Canada; and.
authors.forename: Svetlana V
authors.initials: SV
authors.lastname: Selivanova
authors.affiliation: Sherbrooke Molecular Imaging Center, CRCHUS, Sherbrooke, Quebec, Canada.
authors.forename: Éric
authors.initials: É
authors.lastname: Lavallée
authors.affiliation: Sherbrooke Molecular Imaging Center, CRCHUS, Sherbrooke, Quebec, Canada.
authors.forename: Helena
authors.initials: H
authors.lastname: Senta
authors.affiliation: Sherbrooke Molecular Imaging Center, CRCHUS, Sherbrooke, Quebec, Canada.
authors.forename: Lyne
authors.initials: L
authors.lastname: Caouette
authors.affiliation: Cross Cancer Institute, Edmonton, Alberta, Canada.
authors.forename: Alexander J B
authors.initials: AJB
authors.lastname: McEwan
authors.affiliation: Sherbrooke Molecular Imaging Center, CRCHUS, Sherbrooke, Quebec, Canada.|Department of Nuclear Medicine and Radiobiology, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, Quebec, Canada; and.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Guérin
authors.affiliation: Sherbrooke Molecular Imaging Center, CRCHUS, Sherbrooke, Quebec, Canada.|Department of Nuclear Medicine and Radiobiology, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, Quebec, Canada; and.
authors.forename: Roger
authors.initials: R
authors.lastname: Lecomte
authors.affiliation: Sherbrooke Molecular Imaging Center, CRCHUS, Sherbrooke, Quebec, Canada.|Department of Nuclear Medicine and Radiobiology, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, Quebec, Canada; and.
authors.forename: Éric
authors.initials: É
authors.lastname: Turcotte
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017357:Cyclotrons / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006801:Humans; D007553:Isotope Labeling / Q000295:instrumentation; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D009928:Organ Specificity; D011832:Radiation Injuries / Q000175:diagnosis / Q000209:etiology* / Q000517:prevention & control; D011876:Radionuclide Generators; D019275:Radiopharmaceuticals / Q000009:adverse effects / Q000138:chemical synthesis / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013670:Sodium Pertechnetate Tc 99m / Q000009:adverse effects* / Q000138:chemical synthesis / Q000493:pharmacokinetics*; D013959:Thyroid Diseases / Q000000981:diagnostic imaging* / Q000378:metabolism*; D014018:Tissue Distribution
chemical_list: D019275:Radiopharmaceuticals; D013670:Sodium Pertechnetate Tc 99m
keywords: cyclotron; efficacy; safety; sodium 99mTc-pertechnetate; thyroid imaging