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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

ConditionsClear Cell Renal Cell CarcinomaSarcomatoid Renal Cell CarcinomaStage II Renal Cell CancerStage III Renal Cell CancerStage IV Renal Cell Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Low risk prostate cancer on active surveillance (National Comprehensive Cancer Network [NCCN] very low/low risk)

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Scan

    Procedure/Surgery

    Undergo bone scan

  • Computed Tomography

    Procedure/Surgery

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

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI of the brain

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Zirconium Zr 89 Girentuximab

    Drug

    Given IV

Treatment groups

91 Participants
are divided into 1 treatment group
Group A: Diagnostic (89Zr-DFO-GmAb PET/CT)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

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.

Time frame
Up to 16 weeks from surgical resection

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
At baseline and up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonsson Comprehensive Cancer Center

Lead sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Collaborator

Source ClinicalTrials.gov
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