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1.
J Nucl Med ; 64(10): 1654-1659, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37934025

RESUMO

Despite the recent success of prostate-specific membrane antigen (PSMA)-targeted compounds for theranostic use in prostate cancer (PCa), alternative options for the detection and treatment of PSMA-negative lesions are needed. We have recently developed a novel gastrin-releasing peptide receptor (GRPR) ligand with improved metabolic stability, which might improve diagnostic and therapeutic efficacy and could be valuable for PSMA-negative PCa patients. Our aim was to examine its suitability for theranostic use. We performed a comparative preclinical study on [64Cu]Cu-/[68Ga]Ga-AMTG ([64Cu]Cu-/[68Ga]Ga-α-Me-l-Trp8-RM2) using [64Cu]Cu-/[68Ga]Ga-RM2 ([64Cu]Cu-/[68Ga]Ga-DOTA-Pip5-Phe6-Gln7-Trp8-Ala9-Val10-Gly11-His12-Sta13-Leu14-NH2) as a reference compound and investigated [68Ga]Ga-AMTG in a proof-of-concept study in a PCa patient. Methods: Peptides were labeled with 64Cu (80 °C, 1.0 M NaOAc, pH 5.50) and 68Ga (90 °C, 0.25 M NaOAc, pH 4.50). GRPR affinity (half-maximal inhibitory concentration, room temperature, 2 h) and GRPR-mediated internalization (37 °C, 60 min) were examined on PC-3 cells. Biodistribution studies were performed at 1 h after injection in PC-3 tumor-bearing mice. For a first-in-humans application, 173 MBq of [68Ga]Ga-AMTG were administered intravenously and whole-body PET/CT scans were acquired at 75 min after injection. Results: 64Cu- and 68Ga-labeling proceeded almost quantitatively (>98%). All compounds revealed similarly high GRPR affinity (half-maximal inhibitory concentration, 1.5-4.0 nM) and high receptor-bound fractions (79%-84% of cell-associated activity). In vivo, high activity levels (percentage injected dose per gram) were found in the PC-3 tumor (14.1-15.1 %ID/g) and the pancreas (12.6-30.7 %ID/g), whereas further off-target accumulation was low at 1 h after injection, except for elevated liver uptake observed for both 64Cu-labeled compounds. Overall biodistribution profiles and tumor-to-background ratios were comparable but slightly enhanced for the 68Ga-labeled analogs in most organs. [68Ga]Ga-AMTG confirmed the favorable pharmacokinetics-as evident from preclinical studies-in a patient with metastasized castration-resistant PCa showing intense uptake in several lesions. Conclusion: AMTG is eligible for theranostic use, as labeling with 64Cu and 68Ga, as well as 177Lu (known from previous study), does not have a negative influence on its favorable biodistribution pattern. For this reason, further clinical evaluation is warranted.


Assuntos
Neoplasias , Receptores da Bombesina , Masculino , Humanos , Animais , Camundongos , Radioisótopos de Gálio , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Distribuição Tecidual
2.
J Nurs Meas ; 26(3): 544-565, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30593577

RESUMO

BACKGROUND AND PURPOSE: The Challenging Behavior Scale (CBS) measures the behavior of individuals with dementia. The study aims to translate the English CBS into German (CBS-G) and test its linguistic validity. METHODS: The two-panel approach was used to translate the CBS. Nursing home staff reviewed the unambiguity and familiarity of the CBS-G items and the adequateness of the examples used to describe the items. Content validity indexes (CVI) and modified kappa (k) coefficients were calculated. RESULTS: Most of the CBS-G items had excellent CVI and k values for both unambiguity and familiarity. All examples were viewed as adequate. CONCLUSION: A German version of the CBS that is linguistically equivalent to the original CBS is available but needs further testing of its psychometric properties.


Assuntos
Comportamento , Demência/psicologia , Casas de Saúde , Psicometria , Idoso , Demência/enfermagem , Feminino , Alemanha , Humanos , Masculino , Reprodutibilidade dos Testes , Traduções
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