Single-Photon Emission Computer Tomography Imaging of Prostate-Specific Membrane Antigen (PSMA) Expression in Prostate Cancer Patients Using a Novel Peptide-Based Probe [99mTc]Tc-BQ0413 with Picomolar Affinity to PSMA: A Phase I/II Clinical Study; ACS Pharmacology & Translational Science; Vol. 8, iss. 3

Dades bibliogràfiques
Parent link:ACS Pharmacology & Translational Science.— .— Washington: ACS Publications
Vol. 8, iss. 3.— 2025.— P. 736-747
Altres autors: Medvedeva А. А. Anna Aleksandrovna, Chernov V. I. Vladimir Ivanovich, Larkina M. S. Mariya Sergeevna, Rybina A. N. Anastasiya Nikolaevna, Zelchan (Zeltchan) R. V. Roman Vladimirovich, Bragina O. D. Olga Dmitrievna, Varvashenya R. N. Ruslan Nikolaevich, Zebzeeva O. S. Olga Sergeevna, Bezverkhnyaya E. A. Ekaterina Aleksandrovna, Tolmachev V. Vladimir, Orlova A. Anna
Sumari:Title screen
Radionuclide imaging of prostate-specific membrane antigen (PSMA) expression can be used for staging prostate cancer. The pseudo-peptide [99mTc]Tc-BQ0413 demonstrated high affinity and specificity to PSMA in preclinical evaluation. The purpose of this study was to clinically evaluate the safety and tolerability of a single administration of [99mTc]Tc-BQ0413 as well as study its biodistribution using SPECT to estimate dosimetry. [99mTc]Tc-BQ0413 was studied in a single-center diagnostic Phase I open-label exploratory study. Whole-body planar scintigraphy and SPECT/CT imaging were performed 2, 4, and 6 h after administration of 50, 100, or 150 μg (680 ± 140 MBq) of [99mTc]Tc-BQ0413 in five PCa patients per injected mass (NCT05839990). All injections of [99mTc]Tc-BQ0413 were well tolerated. The elimination of [99mTc]Tc-BQ0413 was predominantly renal. The stable physiological uptake of [99mTc]Tc-BQ0413 was observed in the lacrimal and salivary glands, liver, spleen, and kidneys for all tested peptide-injected masses. The average effective doses were 0.007 ± 0.001, 0.0049 ± 0.0003, and 0.0062 ± 0.0008 mSv/MBq for 50, 100, and 150 μg/injection, respectively. The radionuclide-associated dose burden per patient was 4–7 mSv/study for the given activity. Uptake of [99mTc]Tc-BQ0413 in primary tumors was identified in all patients and increased with the peptide-injected mass. Uptake in lymph nodes and bone metastases was the highest at 100 μg/injected mass. The highest tumor lesion/background ratios were observed 6 h after the administration of 100 μg of [99mTc]Tc-BQ0413. The results of the Phase I study showed that injections of [99mTc]Tc-BQ0413 were well tolerated, safe, and associated with low absorbed doses. Imaging using [99mTc]Tc-BQ0413 enabled the visualization of primary prostate cancer lesions as well as metastases in lymph nodes and bones
Текстовый файл
Idioma:anglès
Publicat: 2025
Matèries:
Accés en línia:https://doi.org/10.1021/acsptsci.4c00637
Format: Electrònic Capítol de llibre
KOHA link:https://koha.lib.tpu.ru/cgi-bin/koha/opac-detail.pl?biblionumber=679784

MARC

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200 1 |a Single-Photon Emission Computer Tomography Imaging of Prostate-Specific Membrane Antigen (PSMA) Expression in Prostate Cancer Patients Using a Novel Peptide-Based Probe [99mTc]Tc-BQ0413 with Picomolar Affinity to PSMA: A Phase I/II Clinical Study  |f Anna Medvedeva, Vladimir Chernov, Maria Larkina [et al.] 
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330 |a Radionuclide imaging of prostate-specific membrane antigen (PSMA) expression can be used for staging prostate cancer. The pseudo-peptide [99mTc]Tc-BQ0413 demonstrated high affinity and specificity to PSMA in preclinical evaluation. The purpose of this study was to clinically evaluate the safety and tolerability of a single administration of [99mTc]Tc-BQ0413 as well as study its biodistribution using SPECT to estimate dosimetry. [99mTc]Tc-BQ0413 was studied in a single-center diagnostic Phase I open-label exploratory study. Whole-body planar scintigraphy and SPECT/CT imaging were performed 2, 4, and 6 h after administration of 50, 100, or 150 μg (680 ± 140 MBq) of [99mTc]Tc-BQ0413 in five PCa patients per injected mass (NCT05839990). All injections of [99mTc]Tc-BQ0413 were well tolerated. The elimination of [99mTc]Tc-BQ0413 was predominantly renal. The stable physiological uptake of [99mTc]Tc-BQ0413 was observed in the lacrimal and salivary glands, liver, spleen, and kidneys for all tested peptide-injected masses. The average effective doses were 0.007 ± 0.001, 0.0049 ± 0.0003, and 0.0062 ± 0.0008 mSv/MBq for 50, 100, and 150 μg/injection, respectively. The radionuclide-associated dose burden per patient was 4–7 mSv/study for the given activity. Uptake of [99mTc]Tc-BQ0413 in primary tumors was identified in all patients and increased with the peptide-injected mass. Uptake in lymph nodes and bone metastases was the highest at 100 μg/injected mass. The highest tumor lesion/background ratios were observed 6 h after the administration of 100 μg of [99mTc]Tc-BQ0413. The results of the Phase I study showed that injections of [99mTc]Tc-BQ0413 were well tolerated, safe, and associated with low absorbed doses. Imaging using [99mTc]Tc-BQ0413 enabled the visualization of primary prostate cancer lesions as well as metastases in lymph nodes and bones 
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461 1 |t ACS Pharmacology & Translational Science  |c Washington  |n ACS Publications 
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701 1 |a Medvedeva  |b А. А.  |g Anna Aleksandrovna  |f 1975-  |c specialist in the field of medical technology  |c research fellow of Tomsk Polytechnic University, Doctor of Medical Sciences  |9 20294 
701 1 |a Chernov  |b V. I.  |c specialist in the field of medical technology  |c lead engineer of Tomsk Polytechnic University, doctor of medical sciences  |f 1962-  |g Vladimir Ivanovich  |9 17725 
701 1 |a Larkina  |b M. S.  |g Mariya Sergeevna  |f 1984-  |c pharmacist  |c Professor; Senior Researcher of the Tomsk Polytechnic University, Doctor of Pharmaceutical Sciences  |9 22417 
701 1 |a Rybina  |b A. N.  |g Anastasiya Nikolaevna 
701 1 |a Zelchan (Zeltchan)  |b R. V.  |c specialist in the field of medical technology  |c Researcher of the Tomsk Polytechnic University, Candidate of Medical Sciences  |f 1984-  |g Roman Vladimirovich  |9 17728 
701 1 |a Bragina  |b O. D.  |c specialist in the field of medical technology  |c Senior Researcher of the Tomsk Polytechnic University, Doctor of Medical Sciences  |f 1986-  |g Olga Dmitrievna  |y Tomsk  |9 19084 
701 1 |a Varvashenya  |b R. N.  |c pharmacist  |c engineer at Tomsk Polytechnic University  |f 1997-  |g Ruslan Nikolaevich  |9 88559 
701 1 |a Zebzeeva  |b O. S.  |g Olga Sergeevna 
701 1 |a Bezverkhnyaya  |b E. A.  |g Ekaterina Aleksandrovna 
701 1 |a Tolmachev  |b V.  |g Vladimir 
701 1 |a Orlova  |b A.  |g Anna 
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