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At least 163 records · Page 9Linked to original sources
PubMed2006

An improved 62Zn/62Cu generator based on a cation exchanger and its fully remote-controlled preparation for clinical use.

OBJECTIVE: The goal of this study was to develop an improved (62)Zn/(62)Cu generator based on cation exchange resin and remote preparation at high radioactivity scale for clinical use. METHODS: A natural Cu target was irradiated with proton beam in the energy range of 30-->19 MeV at a beam current of 10 muA for 1 h to obtain around 1.7 GBq of (62)Zn. The (62)Zn was isolated from the Cu target on an anion exchange column with more than 97% yield within 2.5 h from the EOB. The (62)Zn/(62)Cu generator was prepared by loading the (62)Zn(2+) on a Sep-Pak plus CM cartridge. RESULTS: The generator showed high elution efficiency ( approximately 96%) using a small volume (ca. 3 ml) of a 200-mM glycine solution with a very low breakthrough of (62)Zn (<0.1%). CONCLUSIONS: This (62)Zn/(62)Cu generator has been proven to be highly useful as a source of (62)Cu for the synthesis of (62)Cu-labeled compounds. The clinical application of [(62)Cu]Cu-ATSM produced with this generator has been already approved by the Institutional Review Board at the National Institute of Radiological Sciences.

Cation Exchange Resins↗
PubMed1987

Preparation and evaluation of a hydrous tin(IV) oxide 82Sr/82Rb medical generator system for continuous elution.

Hydrous tin(IV) dioxide in the Na+-form appears to be the most efficient inorganic exchanger for a reliable and versatile clinical 82Rb generator. Continuous elution with a commercial physiological NaCl solution yields 82Rb ranging between 10 and 40% at a flow rate as low as 3 to 10 mL/min respectively. At the same time the Sr breakthrough is less than 1.6 10(-6)%/mL. A clinical generator loaded with 100 mCi 82Sr (150 mCi 85Sr) and continuously eluted for 3 min at a typical flow rate of 5 mL/min yields 40 mCi of 82Rb, 8 nCi of 82Sr and 11 nCi of 85Sr. The total absorbed radiation dose for 40 mCi 82Rb administered is primarily due to 82Rb and has been estimated for the three principal target organs as 760 mrad for the kidneys, 520 mrad for the heartwalls and 276 mrad for the lungs. The 82,85Sr contribution to the dosimetry has been shown to be negligible. The absence of radiolysis with generators loaded with high level of 82Sr was demonstrated by the excellent reproductibility of continuous elution properties of the generator during its practical shelf-life estimated to 5-6 weeks of clinical use which would require more than 30 L of eluent.

Humans↗
PubMedDate not supplied

The AAPM/RSNA physics tutorial for residents. Radiopharmaceuticals.

Radiopharmaceuticals are essential to the performance of nuclear medicine procedures. These radioactive drugs consist of two components: a drug component for localization in a specific tissue or organ and a radioactive component for diagnostic or therapeutic purposes. The majority of radiopharmaceuticals are used for diagnostic imaging procedures. The radioisotopes used for radiopharmaceuticals are produced in a number of ways: as by-products of fission, by means of neutron activation, by cyclotrons, and by generators. These methods produce isotopes with both desirable and undesirable properties. Approximately 80% of all nuclear medicine procedures performed in the United States use radiopharmaceuticals labeled with technetium-99m. The chemical properties of technetium allow relatively simple preparation of Tc-99m compounds by using reagent kits. Quality control testing of radiopharmaceuticals is routinely performed to ensure compliance with various purity standards such as assay for radioactivity, radionuclidic purity, chemical purity, radiochemical purity, pharmaceutical purity, and biologic purity.

Humans↗
PubMed1980

A new generator for ionic gallium-68.

To meet the needs created by the rapid development of positron tomographic techniques, a new Ge-68 leads to Ga-68 generator has been developed. By elution under reduced pressure, this tin dioxide/1 N HCl generator provides a sterile solution of Ga-68 in ionic form, ready for use in the preparation of many radiopharmaceuticals. Since the Ga-68 recovery yield is high (75--80%) and the elution time very short (less than 2 min), these products possess maximum activity. Owing to its very slight Ge-68 leakage (less than 0.0002% per elution), the tin dioxide/HCl generator is long-lasting and, more importantly, the radiotoxicity of the labeled derivatives is kept to a minimum. The ionic Ga-68 obtained in this way has been used to label several radiopharmaceuticals.

Gallium Radioisotopes↗
PubMed1980

81mKr gas generator for lung ventilation study.

A generator of 81mKr was designed and tested. The parent nuclide 81Rb was produced by the 70 MeV proton induced reactions on a Rb2SO4 target. 81mKr was bubbled out with oxygen gas from the 81Rb solution, and collected in a reservoir for lung ventilation studies. The generator was continuously operated at the high flow rate up to 10 1/min. The generator efficiency was 86%. The collection rates in the reservoir were examined under several flow rates. The pure 81mKr isomer was observed wih a NaI (T1) detector at the reservoir.

Humans↗
PubMed1991

Cyclotron production of NCA 99mTc and 99Mo. An alternative non-reactor supply source of instant 99mTc and 99Mo----99mTc generators.

The direct production of no-carrier-added (NCA) 6.02 h 99mTc and of 66 h 99mMo using proton beams of natural Mo targets was investigated. The major objective of this work was to evaluate the potential of utilizing high-intensity proton accelerators as a supply source of 99mTc and 99Mo for use in diagnostic nuclear medicine. The excitation functions for the production of the directly-made 99mTc via the 100Mo(p, 2n)99mTc (Q = -7.85 MeV) reaction, and of its parent 99Mo via the 100Mo(p, pn) 99Mo (Q = -8.30 MeV) and 100Mo(p, 2p)99mNb(15 s)----99Mo (Q = -11.14 MeV) reactions, were measured in the 68-8 MeV energy range. Single and cumulative yields for 99mTc and 99Mo, and for other Tc, Mo, Zr, Nb and Y radiocontaminants were also determined. The prospects of integrating the use of enriched 100Mo targets with high-intensity, dual beam, H- accelerators was analyzed. The potential of this combined method to replace or complement the current reactor-based supply sources of 99Mo----99mTc generators, is also discussed. Finally, a brief analysis is made on the potential use of this combined technology to support the anticipated expansion of nuclear medicine in developing nations.

Molybdenum↗
PubMed1979

A krypton-81m generator for organ ventilation and perfusion investigations.

A sterile pyrogen-free generator for ultra-short half-life 81mKr has been developed. During initial loading, the binding efficiency of 81Rb is 90--99%. The count rate during perfusion is 3 x 10(5) counts per minute for a 1,9 GBq (50 mCi) 81Rb generator. The generator has been used for routine and special investigations of lung perfusion and ventilation and for myocardial perfusion during catheterization.

Heart↗
PubMed1999

Quality control of 99Mo/99Tcm generators: results of a survey of the Radiopharmacy Working Group of the Italian Association of Nuclear Medicine (AIMN).

A multicentre survey of the quality control of 99Tcm generators has been completed: 245 generators from seven different commercial sources were tested over a period of 2 years. The results indicate that the mean pH of the eluates was 5.8 +/- 0.6; the aluminium contents were typically < 10 ppm; the radiochemical purity was 99.8 +/- 0.4% and the median 99Mo content was 3.8 x 10(-4) percent. The elution profiles gave a volume of 1.9 ml to obtain 50% of the total eluted activity and of 4.9 ml to obtain 95%. Other radionuclide impurities and heavy metal breakthrough were evaluated by graphite furnace absorption spectrometry and inductively coupled plasma mass spectrometry. National guidelines for the standardization of radiopharmacy procedures are currently being compiled.

Hydrogen-Ion Concentration↗
PubMed1990

Use of the 82Sr/82Rb generator in clinical PET studies.

The use of the 82Sr/82Rb generator in clinical positron emission tomography (PET) studies of myocardial perfusion has been described. An infusion pump is used to deliver the short-lived 82Rb from the generator to the patient. Various characteristics of the generator and the infusion system are described. The 82Rb yield was 69.8 +/- 13.3% and the 82Sr breakthrough was always less than the limit of 0.02 microCi/mCi 82Rb. The yield of 82Rb increased with the flow rate and the potency of the generator. Patients with coronary artery disease were studied for myocardial perfusion abnormalities by the 82Rb PET technique and images of excellent diagnostic quality were obtained.

Coronary Circulation↗
PubMed1999

Manufacture of strontium-82/rubidium-82 generators and quality control of rubidium-82 chloride for myocardial perfusion imaging in patients using positron emission tomography.

We describe a protocol to manufacture 82Sr/82Rb generators and 82RbCl for myocardial imaging with PET. The generators are manufactured in 3 stages: (1) preparation of a tin oxide column, (2) leak test of the generator column and (3) loading of the generator with 82Sr. The generators produced sterile and non-pyrogenic 82RbCl for i.v. injection. No significant 82Sr/85Sr breakthroughs were observed after elution with 20 1 of saline. The automated system delivered human doses of 82RbCl accurately.

Chlorides↗
PubMed1988

An extension set for 81Rb-81mKr solution generators for lung ventilation studies.

For 81Rb-81mKr solution generators, an extension set has been developed, which strips the 81mKr from the liquid eluate with a stream of air for use in lung ventilation studies. Via a three-way valve the 81Rb-81mKr solution generator can be operated alternately in the perfusion mode or in the ventilation mode. Measurements and calculations have been performed to get more insight into the parameters of interest for an optimum design of the extension set and its operation conditions.

Humans↗
PubMed2000

Simple new method for effective concentration of 188Re solutions from alumina-based 188W-188Re generator.

UNLABELLED: (188)Re is a useful generator-produced radioisotope currently under evaluation for a variety of therapeutic applications, including bone pain palliation and intravascular radiation therapy. Because the (188)W parent is available only in a relatively low specific activity (<0.15-0.19 GBq/mg) from reactor irradiation of enriched (186)W, relatively large volumes of 0.9% saline (>15 mL) are required for elution of the (188)Re daughter from traditional alumina-based (188)W-(188)Re generators. Because these large bolus volumes result in solutions with a relatively low specific volume activity of (188)Re (<1 GBq/mL for the 18.5-GBq generator), the availability of effective methods for eluent concentration is important. Our new approach is based on the use of 0.3 mol/L ammonium acetate as a representative salt of a weak acid instead of saline for generator elution. METHODS: After generator elution, the ammonium acetate generator eluent (15-20 mL) is passed through a tandem IC-H Plus cation (Dowex-H)-anion (QMA Light) column system. Exchange of ammonium cations with hydrogen ions on the cation column forms an acetic acid solution containing perrhenate anions from which the macroscopic levels of the acetate anion of the eluent have been effectively removed. Because perrhenic acid is fully dissociated at this pH, the QMA Light column specifically traps the (188)Re-perrhenate, which is subsequently eluted with a low volume (<1 mL) of saline. Concentration ratios greater than 20:1 are readily achieved with this method. RESULTS: A typical clinical-scale generator loaded with 19.2 GBq (188)W was used to validate the approach. Saline elution provided (188)Re in a 75%-80% yield. Although elution with 0.15 mol/L NH4OAc gave lower yields (55%-60%), use of 0.3 mol/L NH4OAc provided yields comparable with those of saline (70%-75%). (188)W parent breakthrough was not detected after passage of the bolus through the tandem concentration system. Bolus volumes of 15-20 mL, which initially contained as much as 11.1-14.8 GBq (188)Re, were readily concentrated to less than 1 mL saline using QMA Light cartridges. The generator was evaluated for more than 3 mo with no decrease in performance. CONCLUSION: This approach represents a simple, rapid, and effective method using inexpensive disposable components of concentrating solutions of (188)Re for preparation of therapeutic agents.

Aluminum Oxide↗
PubMed1993

Extending the life of a 99Tcm generator: a simple and convenient method for concentrating generator eluate for clinical use.

99Tcm-pertechnetate can conveniently be concentrated 5-20-fold by passing up to 20 ml through a sequence of two (or three) disposable columns, one (or two) to remove chloride and one to concentrate the pertechnetate for subsequent elution with a small volume of saline. This procedure is useful for utilizing eluates with low radioactive concentration in applications that require high radioactive concentration.

Methods↗
PubMed2000

Performance of a 62Zn/62Cu generator in clinical trials of PET perfusion agent 62Cu-PTSM.

UNLABELLED: The 62Zn/62Cu PET generator can be inexpensively produced and distributed from a single production site operating under typical good manufacturing practice guidelines. It therefore has the potential to greatly facilitate development of clinically practical PET. We report generator performance in a study in which 62Cu-pyruvaldehyde-bis(n4-methylthiosemicarbazone (PTSM) myocardial perfusion imaging is compared with 99mTc-sestamibi in the diagnosis of coronary artery disease. The 62Zn/62Cu generator is an improved version of a previously reported system that employs automated synthesis of 62Cu-PTSM. With this approach, the cumbersome step of 18C purification has been eliminated. METHODS: The 62Zn (9.3 h half-life) parent isotope is prepared by proton bombardment of natural copper at 33 MeV. A typical target irradiated with 37.5 microA/h is delivered by 12:00 PM on the day it is to be processed. Purified 62Zn obtained from the target is loaded onto the generator column in 2 mol/L HCl. The generator is eluted using an internal three-channel peristaltic pump, which delivers 2.25 mL eluant (1.8 mol/L NaCl, 0.2 mol/L HCl) through the generator column to elute the 62Cu in 40 s. The same pump simultaneously pumps an equal volume of buffer (0.4 mol/L NaOAc) and 1 mL ligand solution (2 ppm PTSM, 2% EtOH) passing it through a septum into a 35-cc syringe preloaded with 28 mL sterile water. This solution is thoroughly mixed by agitation of the syringe and injected as a bolus through a 0.2 microm filter. The generator is eluted twice before shipping, providing quality assurance samples, and shipped to the clinical site by overnight delivery. Complete quality assurance testing is performed the evening before the generator reaches the clinical site. RESULTS: A total of 34 generators have been produced and shipped to 2 clinical sites for a phase III Food and Drug Administration study. The load activity on the generators at 8:00 AM the day of clinical use was 1.7+/-0.2 GBq (46.7+/-5.6 mCi), and yield was 72%+/-16%. Breakthrough of 62Zn was undetectable by high-purity germanium spectroscopy for all units. Radiochemical purity was 95.4%+/-2.4%. Volume delivered, pH, sterility, and bacterial endotoxin tests yielded passing results on all generators. The entire process of generator production, from target receipt to generator shipment, took less than 6 h and cost approximately $1000, including shipping charges and cyclotron cost. A total of 68 patients were injected with 2 62Cu-PTSM doses, with a mean injected activity of 0.8+/-0.2 GBq (20.5+/-5.3 mCi) with no adverse side effects. CONCLUSION: Results of this work confirm that the 62Zn/62Cu generator is an easily produced, transportable, and inexpensive source of PET radiopharmaceuticals, which can expand the field of clinical PET imaging by providing radiopharmaceuticals to sites not associated with cyclotrons.

Clinical Trials, Phase III as Topic↗
PubMedDate not supplied

Utilization of the 16O(n,p) reaction for monitoring the output of 14 MeV neutron generators.

A system based upon the 16O(n,p) 16N reaction has been developed for monitoring 14-MeV neutron production. The system has proven to be quite applicable for monitoring the output of a disk-shaped neutron source and computer analysis has shown it equally suitable for monitoring the output of cone-shaped neutron sources from gas targets presently being considered for cancer therapy.

Humans↗
PubMed1984

Technetium-99 in generator systems.

Technetium-99m solutions always contain Tc-99. The amount varies considerably, depending on production methods and conditions, generator performance, and the time between production or separation and use. There is increasing evidence that labeling and imaging with some radiopharmaceutical kits is adversely affected when the Tc-99 exceeds certain amounts. The sensitivity of particular kits to Tc-99 depends on the ligand, the amount of usable Sn2+, and the ratio of Tc to ligand. Although Tc-99 formed during production is removed in the final steps of generator manufacture, some may appear in early extractions in the solvent extraction process. If elution or extraction efficiencies are high, any Tc-99 is reduced within about two elutions to an insignificant level that is maintained in subsequent elutions. If efficiencies are below about 40%, however, the ratio of Tc-99 to Tc-99m increases with each elution.

Drug Contamination↗
PubMed1982

Lower-oxidation-state 99mTc in the generator product--its determination and occurrence.

The behaviour of some [99mTc]chlorocomplexes in NaCl solution is described. These compounds of lower-oxidation-state 99mTc are considered as radiochemical impurities in the injection of [99mTc]sodium pertechnetate. This paper reviews some methods for the separation of 99mTc-compounds and the reliability of these methods with respect to the formation of artifacts. Finally, the questions of why and when the radiochemical purity of Na99mTcO4 injection should be controlled are discussed.

Humans↗