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De klinische studie NCT05046665 (ZiPUP) voor Urotheelcarcinoom is afgerond. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium Girentuximab PET in Urothelial Cancer Patients (ZiPUP) Fase 1 11

Afgerond
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De klinische studie NCT05046665 (ZiPUP) onderzocht diagnostiek bij Urotheelcarcinoom. Deze Fase 1 interventioneel studie is nu afgerond. Er werd gestreefd naar inclusie van 11 deelnemers vanaf 14 mei 2021. De studie werd geleid door South Metropolitan Health Service en was gepland te worden voltooid op 9 augustus 2022. Laatste update op ClinicalTrials.gov: 22 april 2024.
Beknopte samenvatting
The aim of this study is to determine if it is practical to use 89Zr-TLX250 PET/CT in the staging and detection of localized and metastatic urothelial carcinoma or bladder cancer.

The primary objective is to evaluate the feasibility of using 89Zr-TLX250 PET/CTas a new diagnostic and staging modality to detect urothelial carcinoma or bladder cancer.

Uitgebreide beschrijving
This will be a non-randomised, non-blinded, single centre, phase 1 feasibility study comparing 89Zr-girentuximab PET with FDG PET in patients with urothelial carcinoma or bladder cancer. This study would include 2 cohorts of adult patients; those with known metastatic urothelial carcinoma and bladder cancer and those undergoing primary staging for recently diagnosed urothelial carcinoma or bladder cancer.

This study...

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Officiële titel

A Single-centre, Open-label, Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP Study)

Aandoeningen
Urotheelcarcinoom
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • ZiPUP
NCT-ID
NCT05046665
Startdatum (Werkelijk)
2021-05-14
Laatste update geplaatst
2024-04-22
Verwachte einddatum
2022-08-09
Inschrijving (Geschat)
11
Studietype
Interventioneel
FASE
Fase 1
Status
Afgerond
Trefwoorden
Glandular and Epithelial
Primaire doel
Diagnostisch
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
OverigeAdministration of 89Zr-Girentuximab
Administration of 89Zr-Girentuximab as per protocol
89Zr-Girentuximab
Administration of 89Zr-girentuximab as per protocol.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Comparison of the sensitivity and specificity of 89Zr-girentuximab PET with FDG PET
Sensitivity and specificity will be established following histological confirmation
Day 1 - Day 90
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
To evaluate the correlation between 89Zr-girentuximab SUV's and degree of urinary carbonic anhydrase IX excretion (cytology and CA-IX via PCR).
89Zr-girentuximab SUV's will be correlated with urinary CA-IX expression
Day 1
Number of participants with treatment related adverse events related to 89Zr-girentuximab administration
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v 5.0 criteria
Day 1 to Day 90
To quantify the correlation between tumour volume using MIM quantitative software and histopathological findings
Tumour burden as defined by volumetric software will be correlated with histopathological results
Day 1 - Day 90
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
  1. Patients aged 18 or older with bladder cancer or urothelial carcinoma who are able to provide informed consent
  2. Negative serum pregnancy test in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
  3. Consent to practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration.

  1. Active malignancy other than urothelial carcinoma or bladder cancer
  2. Administration of a radioisotope within 10 physical half-lives prior to study enrolment.
  3. Administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89Zr-TLX250 or continuing adverse effects from such therapy
  4. Planned antineoplastic therapies for the period between administration of 89Zr-TLX250 and imaging
  5. Serious non-malignant disease that may interfere with the objectives of the study
  6. Renal insufficiency with glomerular filtration rate ≤45 mL/min/1.73m2
  7. Pregnancy or lactation
  8. Exposure to murine or chimeric antibodies within the last 5 years
  9. Known hypersensitivity or human anti-chimeric antibodies against girentuximab
  10. Exposure to any experimental diagnostic or therapeutic drug 30 days prior to the date of planned administration of 89Zr-TLX250
  11. Contraindications to FDG PET/CT
South Metropolitan Health Service logoSouth Metropolitan Health Service
Telix Pharmaceuticals (Innovations) Pty Limited logoTelix Pharmaceuticals
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen

Western Australia

Fiona Stanley Hospital, Murdoch, Western Australia, 6150, Australia