Trial Title:
An Investigational Scan (89Zr-DFO-GmAb PET/CT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer
NCT ID:
NCT06447103
Condition:
Clear Cell Renal Cell Carcinoma
Sarcomatoid Renal Cell Carcinoma
Stage II Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Antibodies, Monoclonal
Conditions: Keywords:
Renal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Diagnostic (89Zr-DFO-GmAb PET/CT)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Scan
Description:
Undergo bone scan
Arm group label:
Diagnostic (89Zr-DFO-GmAb PET/CT)
Other name:
Bone Scintigraphy
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT, PET/CT, and CT of the brain
Arm group label:
Diagnostic (89Zr-DFO-GmAb PET/CT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI of the brain
Arm group label:
Diagnostic (89Zr-DFO-GmAb PET/CT)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Diagnostic (89Zr-DFO-GmAb PET/CT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Diagnostic (89Zr-DFO-GmAb PET/CT)
Intervention type:
Drug
Intervention name:
Zirconium Zr 89 Girentuximab
Description:
Given IV
Arm group label:
Diagnostic (89Zr-DFO-GmAb PET/CT)
Other name:
89Zr-DFO-TFP-girentuximab
Other name:
89Zr-girentuximab
Other name:
89Zr-TLX250
Other name:
Zirconium Zr 89 cG250
Other name:
Zirconium Zr 89-TLX250
Summary:
This phase II trial compares the safety and effectiveness of 89Zr-DFO-GmAb positron
emission tomography (PET)/computed tomography (CT) compared to contrast-enhanced CT after
surgery in detecting clear cell renal cell cancer that has come back (recurrent). For
some patients, the risk of recurrence after surgery remains high. Conventional CT
methods, such as contrast-enhanced CT, may not detect small volume or micrometastatic
disease. PET/CT with radiotracers, such as 89Zr-DFO-GmAb, may improve detection of tumor
cells. Girentuximab (GmAb), a monoclonal antibody, is tagged with zirconium-89, a
radioactive atom (which is also known as an isotope). The zirconium-89 (89Zr) isotope is
attached to girentuximab with desferrioxamine (DFO) and this combined product is called
89Zr-DFO-girentuximab. 89Zr-DFO-girentuximab attaches itself to a protein on the surface
of clear cell renal cell tumor cells called CAIX. PET is an established imaging technique
that utilizes small amounts of radioactivity attached to very minimal amounts of tracer,
in the case of this research, 89Zr-DFO-GmAb. Because some cancers, including clear cell
renal cell cancer, take up 89Zr-DFO-GmAb it can be seen with PET. CT utilizes x-rays that
traverse body from the outside. CT images provide an exact outline of organs and
potential inflammatory tissue where it occurs in patient's body. Using contrast agents
with CT scan to enhance the images (contrast-enhanced CT) is standard of care imaging.
89Zr-DFO-GmAb PET/CT may be safe and effective compared to contrast-enhanced CT in
detecting recurrent clear cell renal cell cancer after surgery.
Detailed description:
PRIMARY OBJECTIVE:
I. To compare the lesion detection rate (i.e., positivity rate per patient) of zirconium
Zr 89 girentuximab (89Zr-DFO-GmAb) PET/CT compared to the standard of care diagnostic
contrast-enhanced CT alone at 4-12 weeks from surgical resection based on blinded
independent central review (BICR).
SECONDARY OBJECTIVES:
I. To establish safety of 89Zr-DFO-GmAb in patients with intermediate-high or high risk
imaged in the post-nephrectomy or metastasectomy setting.
II. To compare the positive predictive value (PPV) of 89Zr-DFO-GmAb PET/CT in patients
with available lesion validation by 1) histopathology (biopsy/resection), 2) evidence of
growth under surveillance or 3) reduction of size under treatment, and 4) unequivocal
confirmation of malignancy on a different imaging modality.
III. To assess the recurrence-free survival of individuals with/without evidence of
disease based on 89Zr-DFO-GmAb PET/CT staging results (PET/CT designated M1 versus [vs]
M0).
EXPLORATORY OBJECTIVES:
I. Correlate level of histological CAIX expression (H Score) from the primary tumor to
89Zr-TLX250 standardized uptake values (SUVs) in patients with visualized disease on
89Zr-DFO-GmAb PET/CT.
II. To identify the standardized uptake value (SUV) cut-off for 89Zr-DFO-GmAb suitable
for the detection of metastatic lesions in the postoperative setting.
III. To evaluate the performance of established prognostic transcriptomic classifiers
(from the nephrectomy specimen) on disease-free survival.
IV. To evaluate if circulating tumor DNA (ctDNA) for the detection of molecular residual
disease (MRD) correlates with the presence of active disease seen on 89Zr-DFO-GmAb PET/CT
or predicts disease-free survival.
OUTLINE:
Patients receive 89Zr-DFO-GmAb intravenously (IV) over 3 minutes on day 0 then undergo
whole body PET/CT and standard of care (SOC) diagnostic contrast-enhanced CT scan on day
7. Patients also blood sample collection on study. In addition, patients may undergo bone
scan and CT or magnetic resonance imaging (MRI) of the brain on study as clinically
indicated.
After completion of study intervention, patients are followed up at 8, 16 and 24 months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18
- Histologically confirmed clear cell renal cell carcinoma (RCC) (ccRCC) (based on
partial/radical nephrectomy/metastasectomy)
- For tumors with extensive sarcomatoid features, if there is evidence of areas
of clear cell and high CAIX expression throughout the tumor on
immunohistochemistry, they will be allowed on study
- Subjects must have undergone definitive treatment of their primary tumor
(partial/radical nephrectomy) +/- resection of metastatic disease to no evidence of
disease (NED) with a prior nephrectomy < 2 years)
- Surgery must have been performed between 4-16 weeks at the time of planned imaging
- Subjects are considered to have a high risk of recurrence based on the following
criteria:
- Intermediate-high risk ccRCC:
- pathologic tumor stage 2 (pT2), grade 4, or sarcomatoid, N0, M0
- pathologic tumor stage 3 (pT3), any grade, N0, M0
- High risk ccRCC:
- pathologic tumor stage 4 (pT4), any grade, N0, M0
- pT any stage, any grade, number of positive nodes (pN+), M0
- M1 now NED: pathologically-confirmed ccRCC, undergoing a resection of a
solitary, isolated soft tissue metastasis within two years from initial
nephrectomy
- Negative serum pregnancy tests in female patients of childbearing potential. (Women
of child bearing potential [WOCBP] require a negative pregnancy test within 24 hours
(urine) prior to receiving investigational product)
- Consent to practice double-barrier contraception until a minimum of 42 days after
89Zr-DFO-GmAb administration
- Individual must be able to remain still and lie flat for duration of the diagnostic
imaging procedure (less than 1 hour)
Exclusion Criteria:
- Inability to provide written informed consent
- Any evidence of residual disease or known metastasis at the time of planned
89Zr-DFO-GmAb administration
- Prior post-operative imaging for confirmation of disease status
- An untreated non-renal malignancy with the following exceptions:
- Low risk prostate cancer on active surveillance (National Comprehensive Cancer
Network [NCCN] very low/low risk)
- Non-melanoma skin cancer
- Any prior treated malignancy meeting the following characteristics:
- Treated stage I or II cancer from which the patient is currently in complete
remission
- A stage III cancer from which the patient is progressing or has been
disease-free for and has required active treatment (e.g. adjuvant or
maintenance therapy) within the past 3 years prior to enrollment
- A hematologic malignancy from which the patient is currently in complete
remission
- Contraindication to the use of iodinated contrast-enhanced CT agents, based on:
- Severe allergy (for which pre-medication cannot limit adverse reactions) or
- Estimated glomerular filtration rate (GFR) ≤ 30 ml/min/1.73m^2
- Prior use of systemic therapy treatment for kidney cancer (PD-1, PD-L1, tyrosine
kinase or TOR inhibitor) or radiotherapy within 4 weeks of enrollment
- Exposure to experimental diagnostic or therapeutic drug within 14 days from date of
planned administration
- Women who are pregnant or breastfeeding
- Known hypersensitivity to girentuximab
- Known inability to remain still and lie flat imaging procedure (about 30 minutes)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA / Jonsson Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Shuch
Phone:
310-794-0987
Email:
BShuch@mednet.ucla.edu
Investigator:
Last name:
Brian Shuch
Email:
Principal Investigator
Start date:
August 6, 2024
Completion date:
December 1, 2030
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Telix Pharmaceuticals (Innovations) Pty Limited
Agency class:
Industry
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06447103
