Carcinoma, Renal CellPhase 1ZIRDAC-JPNCT04496089
Evaluation of Safety, Biodistibution and Sensitivity/Specificity of PET/CT Imaging With 89Zr-TLX250 in Subjects With RCC
A Phase 1 study testing 89Zr-girentuximab in people with Carcinoma, Renal Cell and Clear Cell Renal Cell Carcinoma, run by Telix Pharmaceuticals (Innovations) Pty Limited at 1 site in Japan.
Trial summary
89Zr-TLX250 is a carbonic anydrase IX (CAIX)-targeted imaging agent that is under clinical development as a non-invasive diagnostic imaging agent for teh detection of clear cell renal cell carcinoma (ccRCC). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Clear Cell Renal Cell Carcinoma
- What is being tested?
- 89Zr-girentuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- 1 Aug 2020to 6 Apr 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 1:
- Written and voluntarily given informed consent
- Aged ≥20 years at the time of enrollment
- Suspected renal cell carcinoma who have been diagnosed with a renal mass by CT or MRI performed within 90 days before screening
- Sufficient life expectancy to participate in the study
- Consent to practice barrier contraception (condoms) until a minimum of 42 days and 90 days after 89Zr-TLX250 administration in female and male, respectively
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- Phase 2 Part
- Written and voluntarily given informed consent
- Aged ≥20 years at the time of enrollment
- Imaging evidence of a single indeterminate renal mass of ≤ 7 cm in largest diameter on CT or MRI within 90 days prior to screening
- Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
- Sufficient life expectancy to undergo nephrectomy
- Consent to practice barrier contraception (condoms) until a minimum of 42 days and 90 days after 89Zr-TLX250 administration in female and male, respectively
Who cannot join
- Commonly applied for Phase 1 part and Phase 2 part
- Those who have hypersensitivity to Girentuximab or DFO
- Patients with metastatic renal tumor
- Patients who need treatment for other active malignancies during the study period
- Patients who have undergone chemotherapy, radiation therapy, or immunotherapy within 4 weeks before the administration of the investigational drug, or have continued adverse events of grade 1 (defined in NCI-CTCAE v5.0) or higher
- Patients scheduled for anticancer drug treatment during the period from administration of investigational drug to image collection
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- Patients who have been exposed to mouse or chimeric antibody within the past 5 years
- Patients who have been administered some kind of radionuclide earlier than 10 half-lives of the nuclide.
- Patients with severe, but not fatal disease, for which the principal investigator / investigator has determined that study participation is not appropriate
- Women who are pregnant or breastfeeding. And women with childbearing potential who are not pregnant or breastfeeding but suspected of being pregnant by the blood test at screening and pre-dose (within 24 hours before administration). Pre-dose blood pregnancy test can be replaced with urine test
- Patients who have been administered the drug by any clinical study or clinical trial within 30 days before the scheduled administration of the investigational drug
- Patients who cannot give legally valid consent by himself / herself
- Patients with renal dysfunction whose GFR is 60mL / min / 1.73m2 or less
- Patents who are socially vulnerable (e.g., patients in custody)
- Others who are judged by the principal investigator or investigator to be inappropriate for participation in this trial Applied only to Phase 2 part 15． Patients whose biopsy is more suitable for pathological diagnosis than partial resection or nephrectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Phase I of 89Zr-girentuximab (89Zr-TLX250) to Assess the Safety, Biodistribution, Pharmacokinetics and Sensitivity/Specificity of PET/CT Images in Patients With Suspected Renal Cell Carcinoma Including Clear Cell Renal Cell Carcinoma (ZIRDAC-JP Study)
89Zr-TLX250 is a carbonic anydrase IX (CAIX)-targeted imaging agent that is under clinical development as a non-invasive diagnostic imaging agent for teh detection of clear cell renal cell carcinoma (ccRCC). The Phase 1 study part of this study is to confirm the safety/tolerability and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with suspected renal cell carcinoma (RCC) including clear cell renal cell carcinoma. The Phase 2 component of the study is to to evaluate the sensitivity/specificity of using 89Zr-TLX250 PET/CT images to detect RCC and ccRCC in patients with suspected RCC.
Read the detailed description
Phase 1:
The phase 1 component of this study will be conducted in in 6-10 subjects at one study center, with the objective of confirming the safety/tolerability and the whole-body dose distribution of 89Zr-TLX250. 89Zr-TLX250 will be administered via a single IV injection (at least 3 min) at an activity dose of 37 MBq (± 10%) and at a dose of 10 mg (±10%). After the enrollment of 6 subjects, if the male-to-female ratio is different from the Japanese epidemiological RCC data (male-to-female ratio ≒ 2:1 in 2017), more subjects, up to 10 subjects in total, are to be enrolled.
Blood sampling for pharmacokinetic analysis will be is performed at 0.5, 1, 2, 4, 24, 72 h and during the Day 5 ± 2 imaging visit. The dose distribution will be determined using low-dose, non-contrast-enhanced CT whole body imaging at 0.5, 4, 24, 72 h and Day 5 ± 2. Diagnostic images will be acquired on Day 3 and Day 5 ± 2 using whole body PET/CT-imaging where individual organs will be assessed using Medical Internal Radiation Dose (MIRD) method.
Seven days after the Day 5 ± 2 imaging visit, patients will attend a follow-up visit to conduct safety evaluations and to undergo blood sampling for HACA measurement.
Phase 2:
The phase 2 component of this study will be conducted after the completion of the phase 1 study in 6-10 patients. This part of the study is equivalent to a phase 2, open-label, multi-center (2-5 sites) to assess the sensitivity/specificity of PET/CT images in subjects with suspected but not definitely diagnosed RCC including ccRCC. The study is intended to evaluate the sensitivity and specificity of PET/CT test as a non-invasive test with the CAIX-targeted imaging agent 89Zr-TLX250. The study will include patients who are scheduled to undergo a partial or total nephrectomy. Patients with an indeterminate renal mass with the longest diameter of 7cm or less, by diagnostic imaging, will receive a single administration of 37 MBq (+/- 10%) 89Zr-TLX250. Imaging will then be conducted Day 5 ± 2 post administration. The partial/total nephrectomy will be performed at institutional discretion any time following the PET/CT imaging visit, but no later than 90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a central laboratory.
Image data analyses will be performed by a central image core lab. Qualitative visual analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal lesion, as seen on contrast-enhanced CT or MRI), will be used to assess test performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from the central histological reference laboratory as standard of truth.
- Being tested
- 89Zr-girentuximab
- Keywords
- clear cell renal cell carcinoma, PET/CT imaging, 89Zr-girentuximab, pharmacokinetics, pharmacodynamics, safety, Diagnostic imaging, 89Zr-TLX250
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-girentuximabDiagnostic test
Also called 89Zr-TLX250, 89Zr-DFO-TFP-girentuximab (GTX)
A single dose of 37 MBq (±10%) is administered. The dose per dose is equivalent to girentuximab 10 mg (±10%).
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-girentuximab | Experimental | A single administration of 37 Megabecquerel (MBq) (±10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab Receives: Diagnostic Test: 89Zr-girentuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]
Incidence of abnormal laboratory test results and abnormal vital signs
Measured: 90 days
Determination of the sensitivity and specificity of 89Zr-TLX250 to detect clear cell renal cell carcinoma
The sensitivity and specificity of 89Zr-TLX250 to detect renal cell carcinoma will be established by a diagnostic scan after administration of the investigational product followed by surgery of the indeterminate mass. After surgical removal of the kidney mass , diagnostic histology of the mass will be conducted and used as the "standard of truth" comparator.
Measured: 90 days
Secondary outcomes (8)
Phase 1: Evaluation of the radioactivity distribution and biodistribution/tumor uptake
Whole body PET/CT imaging (from the base of skull to the thigh) performed post-injection using non-contrast-enhanced and low-dose CT for absorption correction.
Measured: 0.5, 4, 24, and 72 hours and Day 5 ± 2
Phase 1: Assessment of tumor uptake
This outcome will be evaluated by determining the absorbed dose after injection with 89Zr-TLX250 in identifiable tumor regions taking into account the tumor volume estimated from imaging performed prior to participation to the study.
Measured: Day 3-5
Phase 2: To evaluate positive predictive value (PPV) of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses
Positive predictive value (PPV) in detecting ccRCC by PT/CT imaging using 89Zr-TLX250 in subjects with undiagnosed solid renal mass
Measured: At end of study , on average of 5 months
Phase 2: To evaluate negative predictive value (NPV) of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses
Negative predictive value (NPV) using 89Zr-TLX250 in subjects with undiagnosed solid renal mass
Measured: At end of study , on average of 5 months
To evaluate accuracy of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses
Determine accuracy in detecting ccRCC by PT/CT imaging using 89Zr-TLX250 in subjects with undiagnosed solid renal mass
Measured: At end of study , on average of 5 months
Phase 2: To evaluate the correlation between 89Zr- girentuximab SUVs and degree of histological carbonic anhydrase IX (CAIX) expression
This outcome will be assessed on all patients. The counts derived from the PET/CT imaging of the renal lesion will be compared with the amount of CAIX expressed in the histologically extracted sample
Measured: Within 90 days
Phase 2: To evaluate inter-reader variability of diagnostic assessments of 89Zr- girentuximab PET/CT images, when performed by multiple readers
This outcome will be conducted on all patients. Three blinded readers operating independently will be used to read each patient PET/CT image and determine if the target lesion is positive for Zr89. A comparison of findings will then be made between the readers for each patient individually.
Measured: This analysis will be conducted through study completion, on average of 5 months
Phase 2: Assessment of differences in a same reader
The difference in evaluations of 89Zr-TLX250 PET/CT images by a same reader is assessed with the use of Cohen's κ coefficient.
Measured: This analysis will be conducted through study completion, on average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start1 Aug 2020
- Primary completion27 Oct 2020
- Study completion6 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- open-label, safety, pharmacokinetic, diagnostic, prospective, multi-center
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noboru Nakaigawa, MD, PhD, Principal investigator, Yokohama City University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496089
- Sponsor's protocol ID
- 89Zr-TLX250-004
- Acronym
- ZIRDAC-JP
- Status last verified
- Oct 2020
- First submitted
- 14 Jul 2020
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Phase I of 89Zr-girentuximab (89Zr-TLX250) to Assess the Safety, Biodistribution, Pharmacokinetics and Sensitivity/Specificity of PET/CT Images in Patients With Suspected Renal Cell Carcinoma Including Clear Cell Renal Cell Carcinoma (ZIRDAC-JP Study)
- ClinicalTrials.gov ID
- NCT04496089
- Acronym / sponsor ID
- ZIRDAC-JP / 89Zr-TLX250-004
- Keywords
- clear cell renal cell carcinoma, PET/CT imaging, 89Zr-girentuximab, pharmacokinetics, pharmacodynamics, safety, Diagnostic imaging, 89Zr-TLX250
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 27 Oct 2020 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 3 Aug 2020 (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.
89Zr-TLX250 is a carbonic anydrase IX (CAIX)-targeted imaging agent that is under clinical development as a non-invasive diagnostic imaging agent for teh detection of clear cell renal cell carcinoma (ccRCC). The Phase 1 study part of this study is to confirm the safety/tolerability and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with suspected renal cell carcinoma (RCC) including clear cell renal cell carcinoma. The Phase 2 component of the study is to to evaluate the sensitivity/specificity of using 89Zr-TLX250 PET/CT images to detect RCC and ccRCC in patients with suspected RCC.
Detailed description
Phase 1:
The phase 1 component of this study will be conducted in in 6-10 subjects at one study center, with the objective of confirming the safety/tolerability and the whole-body dose distribution of 89Zr-TLX250. 89Zr-TLX250 will be administered via a single IV injection (at least 3 min) at an activity dose of 37 MBq (± 10%) and at a dose of 10 mg (±10%). After the enrollment of 6 subjects, if the male-to-female ratio is different from the Japanese epidemiological RCC data (male-to-female ratio ≒ 2:1 in 2017), more subjects, up to 10 subjects in total, are to be enrolled.
Blood sampling for pharmacokinetic analysis will be is performed at 0.5, 1, 2, 4, 24, 72 h and during the Day 5 ± 2 imaging visit. The dose distribution will be determined using low-dose, non-contrast-enhanced CT whole body imaging at 0.5, 4, 24, 72 h and Day 5 ± 2. Diagnostic images will be acquired on Day 3 and Day 5 ± 2 using whole body PET/CT-imaging where individual organs will be assessed using Medical Internal Radiation Dose (MIRD) method.
Seven days after the Day 5 ± 2 imaging visit, patients will attend a follow-up visit to conduct safety evaluations and to undergo blood sampling for HACA measurement.
Phase 2:
The phase 2 component of this study will be conducted after the completion of the phase 1 study in 6-10 patients. This part of the study is equivalent to a phase 2, open-label, multi-center (2-5 sites) to assess the sensitivity/specificity of PET/CT images in subjects with suspected but not definitely diagnosed RCC including ccRCC. The study is intended to evaluate the sensitivity and specificity of PET/CT test as a non-invasive test with the CAIX-targeted imaging agent 89Zr-TLX250. The study will include patients who are scheduled to undergo a partial or total nephrectomy. Patients with an indeterminate renal mass with the longest diameter of 7cm or less, by diagnostic imaging, will receive a single administration of 37 MBq (+/- 10%) 89Zr-TLX250. Imaging will then be conducted Day 5 ± 2 post administration. The partial/total nephrectomy will be performed at institutional discretion any time following the PET/CT imaging visit, but no later than 90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a central laboratory.
Image data analyses will be performed by a central image core lab. Qualitative visual analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal lesion, as seen on contrast-enhanced CT or MRI), will be used to assess test performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from the central histological reference laboratory as standard of truth.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, safety, pharmacokinetic, diagnostic, prospective, multi-center
| Arm | Type | Receives |
|---|---|---|
| 89Zr-girentuximab | Experimental | Diagnostic Test: 89Zr-girentuximabA single administration of 37 Megabecquerel (MBq) (±10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written and voluntarily given informed consent
- Aged ≥20 years at the time of enrollment
- Suspected renal cell carcinoma who have been diagnosed with a renal mass by CT or MRI performed within 90 days before screening
- Sufficient life expectancy to participate in the study
- Consent to practice barrier contraception (condoms) until a minimum of 42 days and 90 days after 89Zr-TLX250 administration in female and male, respectively
Key exclusion criteria (15 listed)
- Commonly applied for Phase 1 part and Phase 2 part
- Those who have hypersensitivity to Girentuximab or DFO
- Patients with metastatic renal tumor
- Patients who need treatment for other active malignancies during the study period
- Patients who have undergone chemotherapy, radiation therapy, or immunotherapy within 4 weeks before the administration of the investigational drug, or have continued adverse events of grade 1 (defined in NCI-CTCAE v5.0) or higher
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-girentuximabAlso: 89Zr-TLX250, 89Zr-DFO-TFP-girentuximab (GTX)A single dose of 37 MBq (±10%) is administered. The dose per dose is equivalent to girentuximab 10 mg (±10%). | Diagnostic test | 89Zr-girentuximab |
Primary outcome
Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]
Time frame: 90 days
Incidence of abnormal laboratory test results and abnormal vital signs
Determination of the sensitivity and specificity of 89Zr-TLX250 to detect clear cell renal cell carcinoma
Time frame: 90 days
The sensitivity and specificity of 89Zr-TLX250 to detect renal cell carcinoma will be established by a diagnostic scan after administration of the investigational product followed by surgery of the indeterminate mass. After surgical removal of the kidney mass , diagnostic histology of the mass will be conducted and used as the "standard of truth" comparator.
8 secondary outcomes
Phase 1: Evaluation of the radioactivity distribution and biodistribution/tumor uptake
Time frame: 0.5, 4, 24, and 72 hours and Day 5 ± 2
Phase 1: Assessment of tumor uptake
Time frame: Day 3-5
Phase 2: To evaluate positive predictive value (PPV) of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses
Time frame: At end of study , on average of 5 months
Phase 2: To evaluate negative predictive value (NPV) of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses
Time frame: At end of study , on average of 5 months
To evaluate accuracy of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses
Time frame: At end of study , on average of 5 months
Phase 2: To evaluate the correlation between 89Zr- girentuximab SUVs and degree of histological carbonic anhydrase IX (CAIX) expression
Time frame: Within 90 days
Phase 2: To evaluate inter-reader variability of diagnostic assessments of 89Zr- girentuximab PET/CT images, when performed by multiple readers
Time frame: This analysis will be conducted through study completion, on average of 5 months
Phase 2: Assessment of differences in a same reader
Time frame: This analysis will be conducted through study completion, on average of 5 months
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 24 Aug 2021.
- 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.
Noboru Nakaigawa, MD, PhD principal investigator
Yokohama City University Hospital
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 Carcinoma, Renal Cell and Clear Cell Renal Cell Carcinoma, run by Telix Pharmaceuticals (Innovations) Pty Limited at 1 site in Japan.
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 13 inclusion and 15 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 24 Aug 2021. 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 Japan. 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?
Incidence of Treatment-Emergent Adverse events [Safety and Tolerability] (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2021.