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89Zr-girentuximab for Renal Cell Carcinoma (89ZR-TLX250 Trial)

Phase 3

Waitlist Available

Led By Pierre Olivier, MD

Research Sponsored by Telix Pharmaceuticals (Innovations) Pty Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this analysis will be conducted after all patients have completed study involvement, an average of 1 year

Awards & highlights

89ZR-TLX250 Trial Summary

This trialuses a new radioactive imaging tool to help diagnose a type of kidney cancer.

Eligible Conditions

Clear Cell Renal Cell Carcinoma

89ZR-TLX250 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this analysis will be conducted after all patients have completed study involvement, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this analysis will be conducted after all patients have completed study involvement, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and this analysis will be conducted after all patients have completed study involvement, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to noninvasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth.

Secondary outcome measures

To define a standardized uptake value (SUV) cut-off for 89Zr-girentuximab, suitable to discriminate ccRCC from non-ccRCC

To determine sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in the subgroup of patients with indeterminate renal masses of ≤ 4 cm in largest diameter (cT1a)

To determine specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in the subgroup of patients with indeterminate renal masses of ≤ 4 cm in largest diameter (cT1a)

+18 more

Other outcome measures

To evaluate distant masses outside the kidney identified on 89Zr-TLX250 whole body PET/CT in patients who present with unexpected evidence of disseminated disease.

To evaluate the correlation between 89Zr-TLX250 SUVs and degree of histological CAIX expression.

To quantitatively estimate achievable radiation absorbed doses (Gy) for therapeutic 177 Lutetium-girentuximab based on single time point 89Zr-girentuximab PET/CT images.

+2 more

89ZR-TLX250 Trial Design

1Treatment groups

Experimental Treatment

Group I: 89Zr-girentuximabExperimental Treatment1 Intervention

A single administration of 37 Megabecquerel (MBq) (±10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab, followed by a diagnostic scan on Day 5 ± 2 days after administration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

89Zr-girentuximab

2020

Completed Phase 3

~310

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Telix Pharmaceuticals (Innovations) Pty LimitedLead Sponsor

17 Previous Clinical Trials

1,046 Total Patients Enrolled

Telix International Pty LtdLead Sponsor

18 Previous Clinical Trials

1,058 Total Patients Enrolled

Pierre Olivier, MDPrincipal InvestigatorCHRU de Nancy - Hôpitaux de Brabois

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study taking place in a lot of different hospitals throughout America?

"Currently, this research is being conducted at 12 different sites. These locations are situated in cities such as Detroit, Baltimore, Atlanta and 12 other locations. If you are interested in enrolling, please choose the site that is closest to you to reduce travel burdens."

Answered by AI

What is the danger of 89Zr-girentuximab to human beings?

"89Zr-girentuximab is in Phase 3 of clinical trials, meaning that while there is data supporting efficacy, there is also extensive safety data. Therefore, our team rates it as a 3."

Answered by AI

What outcomes is this research hoping to uncover?

"The primary outcome of this study, which will be measured over a Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days, is to evaluate the sensitivity and specificity of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth. Further, this study will be assessing secondary outcomes including To determine specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in the subgroup of patients with indeterminate renal masses of ≤ 4 cm in largest diameter ("

Answered by AI

Recent research and studies

clinicaltrials.govStudy

89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study

2019. "89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03849118.