NCT05046665

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2022

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

September 8, 2021

Last Update Submit

April 18, 2024

Conditions

Urothelial Carcinoma

Keywords

Glandular and Epithelial

Outcome Measures

Primary Outcomes (1)

  • 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

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).

    Day 1

  • Number of participants with treatment related adverse events related to 89Zr-girentuximab administration

    Day 1 to Day 90

  • To quantify the correlation between tumour volume using MIM quantitative software and histopathological findings

    Day 1 - Day 90

Study Arms (1)

Administration of 89Zr-Girentuximab

OTHER

Administration of 89Zr-Girentuximab as per protocol

Drug: 89Zr-Girentuximab

Interventions

89Zr-GirentuximabDRUG

Administration of 89Zr-girentuximab as per protocol.

Administration of 89Zr-Girentuximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Related Publications (1)

  • 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.

    PMID: 35428649DERIVED

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 16, 2021

Study Start

May 14, 2021

Primary Completion

August 9, 2022

Study Completion

August 9, 2022

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)