jerry pisze:w Gammed w Warszawie (scyntygrafia) wybranym pacjentom proponują udział w nowym badaniu obrazowym - scyntygrafia z PSMA -t4 czyli cos jak scyntygrafia i PET PSMA razem, badanie celowane w zmiany związane z rakiem prostaty a nie ogolne, jak sama scyntygrafia.
zosia bluszcz pisze:Dzięki za powyższą informację.
Sciślej to ujmując, 3 ośrodki w Polsce:
- GAMMED w Warszawie
- CO Bydgoszcz (CO)
- WSK Wrocław, ul. Weigla 5
prowadzą nabór do badania klinicznego z zastosowaniem dożylnego znacznika izotopowego
[99mTc]Tc-PSMA-T4 opatentowanego przez Narodowe Centrum Badań Jądrowych Polatom.
PL239934B1 - Derivatives of PSMA inhibitors for ⁹⁹ᵐTc labelling by HYNIC, radiopharmaceutical kit, radiopharmaceutical preparations and their use in the diagnosis of prostate cancer
Pochodne inhibitorów PSMA do znakowania 99mTc poprzez HYNIC, zestaw radiofarmaceutyczny, preparaty radiofarmaceutyczne oraz ich zastosowanie w diagnostyce raka prostatyhttps://patents.google.com/patent/PL239934B1/en Badanie ma 3 ramiona:
Ramię A:Rak prostaty średniego ryzyka, zgodnie z definicją zawartą w najnowszej wersji amerykańskich NCCN Guidelines
Większe niż 10% ryzyko zajęcia węzłów chłonnych oceniane za pomocą nomogramu MSKCC
Ramię B:Rak prostaty wysokiego lub bardzo wysokiego ryzyka zgodnie z definicją zawartą w najnowszej wersji amerykańskich NCCN Guidelines
Ramię C:BCR po RP definiowane jako brak spadku PSA do niewykrywalnego poziomu lub niewykrywalne PSA po RP z późniejszym wykrywalnym wzrostem PSA w 2 lub więcej oznaczeniach
lub
BCR po radykalnej RT (definicja wg Phoenix Consensus)
lub
przerzuty wykryte w badaniach obrazowych bez utrzymywania się/nawrotu PSA
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objawy kliniczne sugerujące przerzuty odległe.
A Phase 2/3, Open-Label Study, to Evaluate the Feasibility and Safety of Intravenous [99mTc]Tc-PSMA-T4 in Subjects With Prostate CancerInclusion Criteria:
(...)
- PS ECOG < 2
- Prior diagnosis of any type of prostate cancer with a Gleason score (GlS) above 6.
- Confirmatory prostate biopsy, pelvic MRI and bone scan within 1 month before screening
- Willingness to participate in this study and to obtain written informed consent.
Additional inclusion criteria for each cohort:
Cohort A:
Intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer
Greater than 10% chance of lymph node involvement assessed using the Memorial Sloan Kettering nomogram for probability of lymph node involvement in prostate cancer patients.
Cohort B:
High or very high-risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer
Cohort C:
Biochemical failure after radical prostatectomy defined as failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after RP with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence) OR biochemical failure after definitive radiotherapy based on Phoenix Consensus OR radiographic evidence of metastatic disease without PSA persistence/recurrence OR clinical symptoms suggesting distant metastases.
Exclusion Criteria:
- No histopathological confirmation of prostate cancer.
- Patients with pacemakers or metal parts that prevent pelvic MRI to confirm the presence of prostate cancer.
- Infection with hepatitis B virus (including carriers) during screening, i.e. hepatitis B positive surface antigen (HBsAg) or positive hepatitis C (anti-HCV) antibody.
- Infected with acquired immunodeficiency (HIV).
- Abnormal liver function including a significant increase of liver enzymes like: ALAT, ASPAT, alkaline phosphatase (AP) greater than 5x upper limit normal (ULN) and an increase in bilirubin greater than 2xULN.
- Renal impairment including GFR <30 ml / min.
- Within 6 months before inclusion into the study: myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.);
- Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia), second or higher degree atrio-ventricular (AV) heart block.
- Cerebrovascular accident, transient ischemic attack, acute stroke etc.
- Subjects with pulmonary embolism or deep vein thrombosis have been reported within the last 6 months.
- An active infection that the investigator considers precluding the patient from being included in the study, such as urinary tract infections, respiratory tract infections, and diabetes infection within the diabetic foot with osteomyelitis
Active Comparator: Cohort A - lymph node assessment in intermediate risk group
The patients will undergo [99mTc]Tc-PSMA-T4 semiWB- SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) with additional chest and abdominal CE computed tomography and [99mTc]Tc-MDP bone scan in unfavorable risk prostate cancer patients
Active Comparator: Cohort B - general assessment (bone and lymph nodes) in high and very high-risk group
The patients will undergo [99mTc]TcPSMA-T4 semi-WB- SPECT/CT and CE multiparametric MRI (according to PI-RADS 2.1 protocol), and chest and abdomen CE computed tomography, and skeletal scintigraphy ([99mTc]Tc-MDP bone scan).
Active Comparator: Cohort C - recurrent disease after definitive treatment (radiotherapy or surgery)
The patients will undergo [99mTc]TcPSMA-T4 semiWB- SPECT/CT and the second confirmatory imaging modality or biopsy in the case of evidence on progressive disease (PSA persistence/recurrence or radiographic evidence of metastatic disease or clinical symptoms suggesting metastatic disease).
Poland
GAMMED Centrum Diagnostyczno-Lecznicze
Warszawa, Lelechowska 5, Poland, 02-351 Recruiting
Contact: GENELYTICA 513466270 k.socko@genelytica.com
Principal Investigator: Jarosław Ćwikła, Prof.
Centrum Onkologii im. prof. F. Łukaszczyka
Bydgoszcz, Ul. Dr Izabeli Romanowskiej 2, Poland, 85-796 Recruiting
Contact: GENELYTICA 513466270 k.socko@genelytica.com
Principal Investigator: Bogdan Małkowski, Prof
Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Wrocław, Weigla 5, Poland, 53-114 Recruiting
Contact: GENELYTICA 513466270 k.socko@genelytica.com
Principal Investigator: Andrzej Kołodziejczyk, Drhttps://clinicaltrials.gov/study/NCT058 ... d=ProstateDroga do opracowania radioznacznika PSMA-T4:
[ 99mTc]Tc-PSMA-T4—Novel SPECT Tracer for Metastatic PCa- From Bench to Clinic.pdf
Bułgarski artykuł dot. obrazowania z zastosowaniem SPECT-CT z radioznacznikiem [ 99mTc]Tc-PSMA-T4 u pacjentów z nawrotem raka prostaty:
SPECT-CT imaging with [99mTc]PSMA-T4 in patients with recurrent prostate cancer.pdf
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