AzTrials
AzTrials

Clear Cell Renal Cell CarcinomaPhase 2NCT06447103

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

A Phase 2 study testing Biospecimen Collection, Bone Scan and Computed Tomography in people with Clear Cell Renal Cell Carcinoma and Sarcomatoid Renal Cell Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Bone Scan and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteUnited States
Study dates
6 Aug 2024to 1 Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 16Show fewer
  • 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)

Who cannot join

  • 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
Show all 18Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

    Brian Shuch, 310-794-0987, BShuch@mednet.ucla.edu

    Brian Shuch

    Recruiting

Other trials in United States

About this study

Official title: 89Zr-DFO-GmAb PET/CT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Biospecimen Collection, Bone Scan, Computed Tomography, Magnetic Resonance Imaging, Positron Emission Tomography
Keywords
Renal
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.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT, PET/CT, and CT of the brain

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI of the brain

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Questionnaire AdministrationOther

    Ancillary studies

  • Zirconium Zr 89 GirentuximabDrug

    Also called 89Zr-DFO-TFP-girentuximab, 89Zr-girentuximab, 89Zr-TLX250, Zirconium Zr 89 cG250

    Given IV

Study groups in NCT06447103
Study groupRoleWhat they receive
Diagnostic (89Zr-DFO-GmAb PET/CT)ExperimentalPatients receive 89Zr-DFO-GmAb IV over 3 minutes on day 0 then undergo whole body PET/CT and 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 MRI of the brain on study as clinically indicated.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Zirconium Zr 89 Girentuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lesion detection rate

    Patients will be treated as binary categorization as follows: (i) Patients who have ≥ 1 lesion confirmed to be recurrent disease will be designated positive (recurrence). (ii) Patients with no lesions detected will be designated negative (no recurrence). The analysis of the primary objective will utilize McNemar's test to compare the detection rate between the imaging techniques.

    Measured: Up to 16 weeks from surgical resection

Secondary outcomes (4)

  1. Incidence of adverse events (AEs)

    The total number of AEs will be summarized with grade and attribution. The total number of significant AEs will be summarized with attribution if present. AEs will be descriptive in nature and only counts and percentage will be reported.

    Measured: Up to day 14

  2. Positive predictive value (PPV)

    Will compare PPV of 89Zr-DFO-GmAb PET/CT in subjects designated as having a suspicious lesion on the BICR PET/CT evaluation, will review follow up for 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. As there are no firm estimates to the number of lesions that will be designated as suspicious, there are no planned statistical analyses planned. Would present the total number of cases and the frequency of validation with the 95% confidence interval.

    Measured: Up to 2 years

  3. Recurrence-free survival

    Recurrence-free survival will be calculated using the Kaplan-Meier Method with date and evidence of recurrence based on either clinical annotation by the treating physician or documentation of recurrence by diagnostic imaging or histopathology. Analysis will be descriptive and provide an estimated 2-year recurrence-free survival with 95% confidence interval. A Log-rank test will compare the differences in recurrence-free survival between groups.

    Measured: Up to 2 years

  4. Change in management and perceived clinical utility of the unblinded read/report of positron emission tomography/ computed tomography (PET/CT)

    Questionnaires using Likert scores will be used to determine changes. Analysis will be descriptive.

    Measured: At baseline and up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2024
  2. Study start6 Aug 2024
  3. Primary completion1 Dec 2029 (estimated)
  4. Study completion1 Dec 2030 (estimated)

Resources

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 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
91 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06447103
Sponsor's protocol ID
23-001576
Other IDs
NCI-2024-01928
Status last verified
Jun 2026
First submitted
3 Jun 2024
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Bone Scan and Computed Tomography in people with Clear Cell Renal Cell Carcinoma and Sarcomatoid Renal Cell Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

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 16 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lesion detection rate (time frame: Up to 16 weeks from surgical resection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06447103.

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 15 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in