Real world experience with [99mTc]Tc-HYNIC-iPSMA SPECT prostate cancer detection: interim results from the global NOBLE registry
Abstract Purpose [99mTc]Tc-HYNIC-iPSMA is a novel technetium-99m-labelled small molecule inhibitor of the prostate-specific membrane antigen (PSMA) for detecting prostate cancer (PC). The objective of this registry was to collect and evaluate [99mTc]Tc-HYNIC-iPSMA patient data and images to establis...
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| Language: | English |
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Springer
2024-12-01
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| Series: | EJNMMI Reports |
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| Online Access: | https://doi.org/10.1186/s41824-024-00226-4 |
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| author | Pete Tually Virginia García Quinto Yehia Omar Fuad Novruzov Ryan Yudistiro Mike Sathekge Geoffrey Currie Paul Galette Neel Patel Tracey Brown Gabriel Bolland Rebecca Lo Bue David Cade |
| author_facet | Pete Tually Virginia García Quinto Yehia Omar Fuad Novruzov Ryan Yudistiro Mike Sathekge Geoffrey Currie Paul Galette Neel Patel Tracey Brown Gabriel Bolland Rebecca Lo Bue David Cade |
| author_sort | Pete Tually |
| collection | DOAJ |
| description | Abstract Purpose [99mTc]Tc-HYNIC-iPSMA is a novel technetium-99m-labelled small molecule inhibitor of the prostate-specific membrane antigen (PSMA) for detecting prostate cancer (PC). The objective of this registry was to collect and evaluate [99mTc]Tc-HYNIC-iPSMA patient data and images to establish the safety and tolerability, and clinical utility of this agent in imaging at different stages of PC. Methods Patients 18 to 80 years old with primary staging and metastatic PC were eligible. Patients unable to perform prescribed examinations, undergo a [99mTc]Tc-HYNIC-iPSMA planar and SPECT or SPECT/CT (when available), or sign a patient informed consent form were excluded from the registry. All eligible patients underwent a screening and baseline visit before imaging with [99mTc]Tc-HYNIC-iPSMA. The primary safety endpoint was assessed by collecting and grading all treatment-related adverse events using the Common Terminology Criteria for Adverse Events. Patients were followed until disease progression, death, serious or intolerable adverse events, registry termination by the sponsor, patient withdrawal, or lost to follow-up. Analysis was planned for when data was available from 40 enrolled patients. Results 40 patients enrolled in 6 countries and received [99mTc]Tc-HYNIC-iPSMA tracer administration followed by planar and SPECT imaging. Of the 40 patients included, investigators reported a change in management due to the [99mTc]Tc-HYNIC-iPSMA imaging in 17/40 of patients (42.5%). No adverse events were reported. Conclusions [99mTc]Tc-HYNIC-iPSMA is a promising option to identify PSMA-positive prostate cancer on SPECT and could improve patient access to PSMA imaging worldwide. |
| format | Article |
| id | doaj-art-5efcda62061d47bd9670bd01b2cc4d77 |
| institution | Kabale University |
| issn | 3005-074X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Springer |
| record_format | Article |
| series | EJNMMI Reports |
| spelling | doaj-art-5efcda62061d47bd9670bd01b2cc4d772025-01-05T12:05:06ZengSpringerEJNMMI Reports3005-074X2024-12-018111910.1186/s41824-024-00226-4Real world experience with [99mTc]Tc-HYNIC-iPSMA SPECT prostate cancer detection: interim results from the global NOBLE registryPete Tually0Virginia García Quinto1Yehia Omar2Fuad Novruzov3Ryan Yudistiro4Mike Sathekge5Geoffrey Currie6Paul Galette7Neel Patel8Tracey Brown9Gabriel Bolland10Rebecca Lo Bue11David Cade12Department of Nuclear Medicine, Charles Sturt UniversityHospital Galenia Department of Nuclear MedicineMisr Radiology CenterDepartment of Nuclear Medicine, Azerbaijan National Centre of OncologyDepartment of Nuclear Medicine, Siloam HospitalUniversity of Pretoria Nuclear Medicine DepartmentSchool of Dentistry and Medical Sciences, Charles Sturt UniversityTelix PharmaceuticalsTelix PharmaceuticalsTelix PharmaceuticalsOncidium FoundationOncidium FoundationTelix PharmaceuticalsAbstract Purpose [99mTc]Tc-HYNIC-iPSMA is a novel technetium-99m-labelled small molecule inhibitor of the prostate-specific membrane antigen (PSMA) for detecting prostate cancer (PC). The objective of this registry was to collect and evaluate [99mTc]Tc-HYNIC-iPSMA patient data and images to establish the safety and tolerability, and clinical utility of this agent in imaging at different stages of PC. Methods Patients 18 to 80 years old with primary staging and metastatic PC were eligible. Patients unable to perform prescribed examinations, undergo a [99mTc]Tc-HYNIC-iPSMA planar and SPECT or SPECT/CT (when available), or sign a patient informed consent form were excluded from the registry. All eligible patients underwent a screening and baseline visit before imaging with [99mTc]Tc-HYNIC-iPSMA. The primary safety endpoint was assessed by collecting and grading all treatment-related adverse events using the Common Terminology Criteria for Adverse Events. Patients were followed until disease progression, death, serious or intolerable adverse events, registry termination by the sponsor, patient withdrawal, or lost to follow-up. Analysis was planned for when data was available from 40 enrolled patients. Results 40 patients enrolled in 6 countries and received [99mTc]Tc-HYNIC-iPSMA tracer administration followed by planar and SPECT imaging. Of the 40 patients included, investigators reported a change in management due to the [99mTc]Tc-HYNIC-iPSMA imaging in 17/40 of patients (42.5%). No adverse events were reported. Conclusions [99mTc]Tc-HYNIC-iPSMA is a promising option to identify PSMA-positive prostate cancer on SPECT and could improve patient access to PSMA imaging worldwide.https://doi.org/10.1186/s41824-024-00226-499mTc-HYNIC-iPSMASPECTTc-99m-iPSMAPET/CTProstate cancerPSMA |
| spellingShingle | Pete Tually Virginia García Quinto Yehia Omar Fuad Novruzov Ryan Yudistiro Mike Sathekge Geoffrey Currie Paul Galette Neel Patel Tracey Brown Gabriel Bolland Rebecca Lo Bue David Cade Real world experience with [99mTc]Tc-HYNIC-iPSMA SPECT prostate cancer detection: interim results from the global NOBLE registry EJNMMI Reports 99mTc-HYNIC-iPSMA SPECT Tc-99m-iPSMA PET/CT Prostate cancer PSMA |
| title | Real world experience with [99mTc]Tc-HYNIC-iPSMA SPECT prostate cancer detection: interim results from the global NOBLE registry |
| title_full | Real world experience with [99mTc]Tc-HYNIC-iPSMA SPECT prostate cancer detection: interim results from the global NOBLE registry |
| title_fullStr | Real world experience with [99mTc]Tc-HYNIC-iPSMA SPECT prostate cancer detection: interim results from the global NOBLE registry |
| title_full_unstemmed | Real world experience with [99mTc]Tc-HYNIC-iPSMA SPECT prostate cancer detection: interim results from the global NOBLE registry |
| title_short | Real world experience with [99mTc]Tc-HYNIC-iPSMA SPECT prostate cancer detection: interim results from the global NOBLE registry |
| title_sort | real world experience with 99mtc tc hynic ipsma spect prostate cancer detection interim results from the global noble registry |
| topic | 99mTc-HYNIC-iPSMA SPECT Tc-99m-iPSMA PET/CT Prostate cancer PSMA |
| url | https://doi.org/10.1186/s41824-024-00226-4 |
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