Urothelial CarcinomaPhase 1ZiPUPNCT05046665
Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium Girentuximab PET in Urothelial Cancer Patients
A Phase 1 study testing 89Zr-Girentuximab in people with Urothelial Carcinoma, run by South Metropolitan Health Service at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- 89Zr-Girentuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteAustralia
- Study dates
- 14 May 2021to 9 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 or older with bladder cancer or urothelial carcinoma who are able to provide informed consent
- 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.
- Consent to practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration.
Who cannot join
- Active malignancy other than urothelial carcinoma or bladder cancer
- Administration of a radioisotope within 10 physical half-lives prior to study enrolment.
- Administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89Zr-TLX250 or continuing adverse effects from such therapy
- Planned antineoplastic therapies for the period between administration of 89Zr-TLX250 and imaging
- Serious non-malignant disease that may interfere with the objectives of the study
- Renal insufficiency with glomerular filtration rate ≤45 mL/min/1.73m2
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- Pregnancy or lactation
- Exposure to murine or chimeric antibodies within the last 5 years
- Known hypersensitivity or human anti-chimeric antibodies against girentuximab
- Exposure to any experimental diagnostic or therapeutic drug 30 days prior to the date of planned administration of 89Zr-TLX250
- Contraindications to FDG PET/CT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the detailed description
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 is open-label, single centre and eligible patients will receive a single administration of study drug prior to imaging on day 5 (+/- 2 days). PET scans will be independently interpreted by nuclear medicine physicians blinded to the FDG PET findings. For patients proceeding to radical cystectomy, subsequent histological confirmation of areas of increased uptake will be retrospectively correlated with both PET scans.
- Conditions
- Urothelial Carcinoma
- Being tested
- 89Zr-Girentuximab
- Keywords
- Glandular and Epithelial
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-GirentuximabDrug
Administration of 89Zr-girentuximab as per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Administration of 89Zr-Girentuximab | Other | Administration of 89Zr-Girentuximab as per protocol Receives: Drug: 89Zr-Girentuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the sensitivity and specificity of 89Zr-girentuximab PET with FDG PET
Sensitivity and specificity will be established following histological confirmation
Measured: Day 1 - Day 90
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Day 1 - Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start14 May 2021
- Primary completion9 Aug 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Metropolitan Health Service
- Sponsor type
- Other government
- Collaborators
- Telix Pharmaceuticals (Innovations) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046665
- Sponsor's protocol ID
- ZiPUP
- Acronym
- ZiPUP
- Status last verified
- Apr 2024
- First submitted
- 8 Sep 2021
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Zubaidi M, Viswambaram P, McCombie S, Liow E, Lenzo N, Ferguson T, Redfern AD, Gauci R, Hayne D. 89Zirconium-labelled girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP): protocol for a phase I trial of a novel staging modality for urothelial carcinoma. BMJ Open. 2022 Apr 15;12(4):e060478. doi: 10.1136/bmjopen-2021-060478.
PubMed 35428649
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05046665
- Acronym / sponsor ID
- ZiPUP / ZiPUP
- Conditions
- Urothelial Carcinoma
- Keywords
- Glandular and Epithelial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- South Metropolitan Health ServiceOther government
- Collaborators
- Telix Pharmaceuticals (Innovations) Pty Limited
- Study start
- 14 May 2021 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 is open-label, single centre and eligible patients will receive a single administration of study drug prior to imaging on day 5 (+/- 2 days). PET scans will be independently interpreted by nuclear medicine physicians blinded to the FDG PET findings. For patients proceeding to radical cystectomy, subsequent histological confirmation of areas of increased uptake will be retrospectively correlated with both PET scans.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Administration of 89Zr-Girentuximab | Other | Drug: 89Zr-GirentuximabAdministration of 89Zr-Girentuximab as per protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 or older with bladder cancer or urothelial carcinoma who are able to provide informed consent
- 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.
- Consent to practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration.
Key exclusion criteria (11 listed)
- Active malignancy other than urothelial carcinoma or bladder cancer
- Administration of a radioisotope within 10 physical half-lives prior to study enrolment.
- Administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89Zr-TLX250 or continuing adverse effects from such therapy
- Planned antineoplastic therapies for the period between administration of 89Zr-TLX250 and imaging
- Serious non-malignant disease that may interfere with the objectives of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-GirentuximabAdministration of 89Zr-girentuximab as per protocol. | Drug | Administration of 89Zr-Girentuximab |
Primary outcome
Comparison of the sensitivity and specificity of 89Zr-girentuximab PET with FDG PET
Time frame: Day 1 - Day 90
Sensitivity and specificity will be established following histological confirmation
3 secondary outcomes
To evaluate the correlation between 89Zr-girentuximab SUV's and degree of urinary carbonic anhydrase IX excretion (cytology and CA-IX via PCR).
Time frame: Day 1
Number of participants with treatment related adverse events related to 89Zr-girentuximab administration
Time frame: Day 1 to Day 90
To quantify the correlation between tumour volume using MIM quantitative software and histopathological findings
Time frame: Day 1 - Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Derived from this study: PubMed 35428649Al-Zubaidi M, Viswambaram P, McCombie S, Liow E, Lenzo N, Ferguson T, Redfern AD, Gauci R, Hayne D. 89Zirconium-labelled girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP): protocol for a phase I trial of a novel staging modality for urothelial carcinoma. BMJ Open. 2022 Apr 15;12(4):e060478. doi: 10.1136/bmjopen-2021-060478.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 89Zr-Girentuximab in people with Urothelial Carcinoma, run by South Metropolitan Health Service at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the sensitivity and specificity of 89Zr-girentuximab PET with FDG PET (time frame: Day 1 - Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05046665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.