New imaging method for detecting recurrent kidney cancer after surgery
89Zr-DFO-GmAb PET/CT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery
This study is testing a new imaging method to see if it can better detect kidney cancer returning after surgery compared to the usual imaging techniques.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 91 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | girentuximab |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06447103 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of 89Zr-DFO-GmAb PET/CT compared to traditional contrast-enhanced CT in identifying recurrent clear cell renal cell carcinoma after surgical treatment. The study aims to determine the lesion detection rate of the new imaging technique, assess its safety, and compare its positive predictive value against established diagnostic methods. Patients will undergo imaging 4-12 weeks post-surgery to monitor for signs of cancer recurrence. The trial also explores the correlation between tumor characteristics and imaging results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed clear cell renal cell carcinoma who have undergone surgery within the last 4-16 weeks.
Not a fit: Patients with non-clear cell renal cell carcinoma or those who have not had recent surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of recurrent kidney cancer, allowing for earlier and more effective treatment options.
How similar studies have performed: Other studies have shown promising results with similar imaging approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Brian Shuch — UCLA / Jonsson Comprehensive Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.