Primary Objective:To evaluate sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth.Secondary…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity and Specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC
Secondary outcome
- Further test performance parameters
- Standardized uptake value (SUV)
- Inter-reader variability
- Safety
- Exploratory Variable
Background summary
In this research a new promising image-forming technique is applied. Here a PET
(Positron Emission Tomography) scan and CT (computer tomography) scan is made
after administration of an imaging agent. This image-forming agent
(89Zr-girentuximab) consists of girentuximab coupled to a small amount of a
radioactive substance (zirconium-89).
Girentuximab is an antibody (a substance that can bind to other substances in
the human body, eg proteins). Research in thousands of patients has shown that
after administration, girentuximab binds to a protein which is common in a form
of kidney cancer that often occurs; the clear cell renal cell carcinoma.
With the aid of a PET / CT scan, 89Zr-girentuximab can be visualized and thus
also the tumor and / or possible metastases. Only in the case of clear cell
renal cell carcinoma will the tumor be visible on the scan. Moreover, it
appears that if the tumor is not visible, there is a big chance that the
abnormality is benign or that it is a less aggressive form of kidney cancer.
In previous research girentuximab has been linked to zirconium-89
(89Zr-girentuximab) and administered in more than 40 patients. The results of
this study have shown that the product can be safely used as an imaging agent
for the detection of clear cell renal cell carcinoma.
It is now important to examine 89Zr-girentuximab in a larger number of patients
to determine whether the drug can correctly demonstrate whether it is a clear
cell renal cell carcinoma. The aim of this research is therefore to determine
whether it is possible to correctly determine the nature of the established or
suspected cancer in the kidneys after administration of 89Zr-girentuximab.
If the study is successful, it could prevent the need for a biopsy or
unnecessary surgery for a benign tumor.
Study objective
Primary Objective:
To evaluate sensitivity and specificity of qualitative assessment of PET/CT
imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with
indeterminate renal masses, using histology as standard of truth.
Secondary Objectives:
1 & 2. To determine sensitivity (1) and specificity (2) 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)
3. To identify a standardized uptake value (SUV) cut-off for 89Zr TLX250,
suitable to discriminate ccRCC from non-ccRCC
4. To determine inter-reader variability of diagnostic assessments of
89Zr-TLX250 PET/CT images, when performed by multiple readers
5 & 6. To determine inter-reader (5) and intra-reader (6) variability of
diagnostic assessments of 89Zr-TLX250 PET/CT images.
7. To establish safety and tolerability of 89Zr-TLX250 in patients with
inderterminate renal masses.
8. To evaluate sensivity and specificity of 89Zr-TLX250 PET/CT imaging to
detect ccRCC in patients with IRMs <= 3cm, IRMs <= 2cm and Bosniak 3 and 4
lesions.
Study design
This will be a confirmatory, prospective, open-label, multi-centre phase 3
study to evaluate sensitivity and specificity of 89Zr-TLX250 PET/CT imaging to
non-invasively detect clear cell renal cell cancer (ccRCC) in adult patients
with indeterminate renal masses (IRM), scheduled for partial or total
nephrectomy.
Study burden and risks
- The use of an intravenous infusion for administration of the IP and
laboratory blooddraw may be accompanied by a mild bruising and in rare cases
with a transient inflammation of the vessel wall. After the initial irritation
following the insertion of the cannula the blooddraw can ussually performed
painless and without significant irritation
- There is a small to moderate chance of discomfort associated with lying in a
scanner (eg back pain
as a result of lying still)
- There is an additional risk of developing stochastic effects after exposure
to ionizing
radiation. Because the amount of radiation used in this study falls into the
clinical-diagnostic range, the chance is considered very small.
- There is a chance of developing an allergic reaction for the IMP or one of
the components. Because allergic reactions have never been seen in various
preclinical and clinical studies this chance is considered very small.
The burden and risks associated with study participation are described in
detail in the Patient Information Leaflet.
Flemington Road 55 (Suite 40)
North Melbourne VIC 3051
AU
Flemington Road 55 (Suite 40)
North Melbourne VIC 3051
AU
Listed location countries
Age
Inclusion criteria
- Male or female >= 18 years of age
- Imaging evidence of a single indeterminate renal mass of <= 7 cm in largest
diameter (tumour stage cT1), on standard of care imaging, based on national
standards, not older than 90 days on Day 0, but performed before any screening
procedure.
- Scheduled for lesion resection as part of regular diagnostic work-up within
90 days from planned 89Zr-TLX250 administration.
- Sufficient life expectancy to justify nephrectomy.
- Consent to practise highly effective contraception until a minimum of 42 days
after 89Zr-TLX250 administration.
Exclusion criteria
- A biopsy procedure only (rather than partial or total nephrectomy) planned
for histological species delineation of IRM
- Renal mass known to be a metastasis of another primary tumour.
- Active non-renal malignancy requiring therapy during the time frame of the
study participation.
- Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the
planned administration of 89Zr -TLX250 or continuing adverse effects (> grade
1) from such therapy (Common Terminology Criteria for Adverse Events [CTCAE]
version 5.0).
- Planned antineoplastic therapies (for the period between administration of
89Zr-TLX250 and imaging).
- Exposure to murine or chimeric antibodies within the last 5 years.
- Previous administration of any radionuclide within 10 half-lives of the same
- Serious non-malignant disease
- Known hypersensitivity to girentuximab or DFO (desferoxamine)
- Renal insufficiency with GFR <= 45 mL/min/ 1.73 m²
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-002773-21-NL |
| ClinicalTrials.gov | NCT03849118 |
| CCMO | NL67645.031.18 |