Experience in Production of 68Ga-DOTA-NOC for Clinical Use Under an Expanded Access IND

[68Ga]Ga-DOTA-NOC was produced under an Expanded Access IND for 174 clinical PET/CT studies to evaluate patients with neuroendocrine tumors. Production employed either the TiO2-based Eckert & Ziegler (EZAG) 68Ge/68Ga-generator (with fractionated elution), or the SiO2-based ITG 68Ge/68Ga-generator. In both cases, [68Ga]Ga-DOTA-NOC was reliably produced, without pre-synthesis purification of the68Ga generator eluate, using readily-implemented manual synthesis procedures. [68Ga]Ga-DOTA-NOC radiochemical purity averaged 99.2±0.4%. Administered 68Ga dose averaged 181±22 MBq, and administered peptide mass averaged 43.2±5.2 µg (n=47) and 23.9±5.7 µg (n=127), respectively, using the EZAG and ITG generators. At dose expiration, 68Ge breakthrough in the final product averaged 2.7×10−7% and 5.4×10−5% using the EZAG and ITG generators, respectively

Flight Research at Ames: Fifty-Seven Years of Development and Validation of Aeronautical Technology

This NASA special publication presents a general overview of the flight research that has been conducted at Ames Research Center over the last 57 years. Icing research, transonic model testing, aerodynamics, variable stability aircraft, boundary layer control, short takeoff and landing (STOL), vertical/ short takeoff and landing (V/STOL) and rotorcraft research are among the major topics of interest discussed. Flying qualities, stability and control, performance evaluations, gunsight tracking and guidance and control displays research are also presented. An epilogue is included which presents the significant contributions that came about as a result of research and development conducted at Ames

Performance of a 62Zn/62Cu microgenerator in kit-based synthesis and delivery of [62Cu]Cu–ETS for PET perfusion imaging

The performance of a commercially produced 62Zn/62Cu microgenerator system, and an associated kit-based radiopharmaceutical synthesis method, was evaluated for clinical site production of [62Cu]Cu-ETS (ethylglyoxal bis(thiosemicarbazonato)copper(II)), an investigational agent for PET perfusion imaging. Using 37 generators, containing 1.84 ± 0.23 GBq 62Zn at 9:00 AM on the day of clinical use, a total of 45 patient doses of [62Cu]Cu-ETS (672 ± 172 MBq) were delivered without difficulty. 62Cu elution yields were high (approximately 90%), accompanied by extremely low 62Zn breakthrough (<0.001%). Radiopharmaceutical preparation, from the start-of-elution to time-of-injection, consumed less than five minutes. The 62Zn/62Cu microgenerator was a dependable source of short-lived positron-emitting 62Cu, and the kit-based synthesis proved to be rapid, robust, and highly reliable for “on-demand” delivery of [62Cu]Cu-ETS for PET perfusion imaging

14- by 22-Foot Subsonic Tunnel Laser Velocimeter Upgrade

A long-focal length laser velocimeter constructed in the early 1980's was upgraded using current technology to improve usability, reliability and future serviceability. The original, free-space optics were replaced with a state-of-the-art fiber-optic subsystem which allowed most of the optics, including the laser, to be remote from the harsh tunnel environment. General purpose high-speed digitizers were incorporated in a standard modular data acquisition system, along with custom signal processing software executed on a desktop computer, served as the replacement for the signal processors. The resulting system increased optical sensitivity with real-time signal/data processing that produced measurement precisions exceeding those of the original system. Monte Carlo simulations, along with laboratory and wind tunnel investigations were used to determine system characteristics and measurement precision

Non-locking screw insertion:No benefit seen if tightness exceeds 80% of the maximum torque

Screws are the most commonly used orthopaedic implant, however they are frequently overtightened when inserted. Using screw, bone and screw hole characteristics, maximum torque for a screw hole is predicted prior to insertion. Using this, optimum tightness as a percentage of the maximum torque is investigated as functions of compression and pullout forces. This data set provides the raw data for these investigations. The methodology is described in detail in the related manuscript: Fletcher, J., Ehrhardt, B., MacLeod, A., Whitehouse, M., Gill, H. & Preatoni, E. 2019. Non-locking screw insertion: No benefit seen if tightness exceeds 80% of the maximum torque. Clinical Biomechanics. https://doi.org/10.1016/j.clinbiomech.2019.07.009Biomechanical testing using juvenile bovine bone'R' software, v3.3.3 (R: A language and environment for statistical computing. R Foundation for Statistical Computing)

Supersonic Flow Field Investigation Using a Fiber-optic based Doppler Global Velocimeter

A three-component fiber-optic based Doppler Global Velocimeter was constructed, evaluated and used to measure shock structures about a low-sonic boom model in a Mach 2 flow. The system was designed to have maximum flexibility in its ability to measure flows with restricted optical access and in various facilities. System layout is described along with techniques developed for production supersonic testing. System evaluation in the Unitary Plan Wind Tunnel showed a common acceptance angle of f4 among the three views with velocity measurement resolutions comparable with free-space systems. Flow field measurements of shock structures above a flat plate with an attached ellipsoid-cylinder store and a low-sonic boom model are presented to demonstrate the capabilities of the system during production testing

COMPTEL all-sky imaging at 2.2 MeV

It is now generally accepted that accretion of matter onto a compact object (white dwarf, neutron star or black hole) is one of the most efficient processes in the universe for producing high energy radiations. Measurements of the γ-ray emission will provide a potentially valuable means for furthering our understanding of the accretion process. Here we focus on neutroncapture processes, which can be expected in any situation where energetic neutrons may be produced and where the liberated neutrons will interact with matter before they decay (where they have a chance of undergoing some type of neutron capture). Line emission at 2.2 MeV, resulting from neutron capture on hydrogen, is believed to be the most important neutroncapture emission. Observations of this line in particular would provide a probe of neutronproduction processes (i.e., the energetic particle interactions) within the accretion flow. Here we report on the results of our effort to image the full sky at 2.2 MeV using data from the COMPTELexperiment on the Compton Gamma-Ray Observatory (CGRO)

Estimation of Radiation Dosimetry for 68Ga-HBED-CC (PSMA-11) in Patients with Suspected Recurrence of Prostate Cancer

Introduction This study was performed to estimate the human radiation dosimetry for [68Ga]Ga-HBED-CC (PSMA-11) (68Ga PSMA-11). Methods Under an RDRC-approved research protocol, we evaluated the biodistribution and pharmacokinetics of 68Ga PSMA-11 with serial PET imaging following intravenous administration to nine prostate cancer patients in whom clinical [11C]acetate PET/CT exams had been independently performed under Expanded Access IND 118,204. List-mode imaging was performed over the initial 0–10 min post-injection with the pelvis in the field-of-view. Whole-body images were acquired, pelvis-to-head, at 15, 60, and 90-min post-injection. Additional images of the pelvis were acquired at 40-min and 115-min, and voided urine collected from each subject at 48-min and 120-min post-injection. Radiation dosimetry estimates were calculated from these data using the OLINDA software package. Results Renal uptake was high and relatively invariant, ranging from 11% to 14% of the injected dose between 15 and 90-min post-injection. Radioactivity collected in the voided urine accounted for 14% of the injected dose over a period of 120-min. Lymph nodes and skeletal metastases suspicious for prostate cancer recurrence were detected in a greater number of patients using 68Ga PSMA-11 than using 11C-acetate. Conclusion Kidneys are the critical organ following 68Ga PSMA-11 administration, receiving an estimated dose of 0.413 mGy/MBq. Advances in knowledge and implications for patient care This study confirms that the kidneys will be the critical organ following intravenous administration of 68Ga PSMA-11, and provided data consistent with the expectation that 68Ga PSMA-11 will be superior to [11C]acetate for defining sites of recurrence in prostate cancer patients presenting with biochemical relapse

Coronary arteriographic findings in black patients and risk markers for coronary artery disease

Coronary arteriographic results are reported in 1535 black patients: 751 men (mean age 57 +/- 11) and 784 women (mean age 59 +/- 11). Among the black men 19%, 15%, 21%, and 4% had single-, double-, and triple-vessel and left main disease, respectively. Among the black women there were 12%, 10%, 15%, and 3% with similar involvement. Logistic regression models showed that most of the recognized risk factors were positively correlated with significant (at least one artery with >/= 50% stenosis) coronary disease, but a history of hypertension was not a significant independent predictor in either sex. ECG evidence of previous infarction increased the odds of detecting significant coronary disease by the greatest amount when controlling for other significant risk markers in women. In men both previous infarction and atypical pain (negative) were equally important. This study confirms but does not explain previous reports that have revealed less than expected angiographic evidence of significant coronary artery disease in black compared with white persons

High Energy Hadron-Nucleus Cross Sections and Their Extrapolation to Cosmic Ray Energies

Old models of the scattering of composite systems based on the Glauber model of multiple diffraction are applied to hadron-nucleus scattering. We obtain an excellent fit with only two free parameters to the highest energy hadron-nucleus data available. Because of the quality of the fit and the simplicity of the model it is argued that it should continue to be reliable up to the highest cosmic ray energies. Logarithmic extrapolations of proton-proton and proton-antiproton data are used to calculate the proton-air cross sections at very high energy. Finally, it is observed that if the exponential behavior of the proton-antiproton diffraction peak continues into the few TeV energy range it will violate partial wave unitarity. We propose a simple modification that will guarantee unitarity throughout the cosmic ray energy region.Comment: 8 pages, 9 postscript figures. This manuscript replaces a partial manuscript incorrectly submitte