New imaging method for detecting recurrent kidney cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UCLA / Jonsson Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Brian Shuch — UCLA / Jonsson Comprehensive Cancer Center

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adding CBM588 to pembrolizumab after surgery for kidney cancer

  This trial tests whether adding CBM588 to pembrolizumab after kidney cancer surgery helps prevent recurrence compared with pembrolizumab alone.

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07037004

• Cadonilimab and Lenvatinib in advanced kidney cancer

  This study tests whether Cadonilimab plus Lenvatinib can help adults with unresectable, advanced renal cell carcinoma, especially clear cell type, after prior treatments.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Panjiayuan Nanli · NCT07909265

• CAIX-targeted PET/CT imaging in solid tumors

  Researchers are testing a CAIX-targeted PET/CT imaging agent to see if it detects and reflects CAIX levels in solid tumors like clear cell renal cell carcinoma, NSCLC, and breast cancer.

  Recruiting Zhongnan Hospital · Wuhan, Hubei · NCT07833085

• Immune cell therapy for advanced clear cell kidney cancer

  This study tests a patient's own tumor-infiltrating lymphocytes (TIL) therapy, given after conditioning with chemotherapy and then interleukin-2, in adults with advanced clear cell renal cell carcinoma who have tried prior treatments.

  Recruiting at 2 sites Phase 1 Hangzhou Huasai Biomedicine Co., Ltd. · Beijing and 1 other locations · NCT07770802

• Theranostic pair labeled PD-32766D/T in CA9-positive clear cell kidney cancer

  This study tests a matching diagnostic agent PD-32766D and a therapeutic agent PD-32766T in adults with CA9-expressing clear cell renal cell carcinoma to see if the treatment is safe and shows signs of effect.

  Recruiting Phase 1 PeptiDream Inc. · Omaha, Nebraska · NCT07688187

• LNK001 CAR T therapy in advanced clear cell kidney cancer

  This study tests a CAR T-cell therapy called LNK001 to see if it can help people with advanced clear cell renal cell carcinoma after other treatments.

  Recruiting Phase 1 M.D. Anderson Cancer Center · Houston, Texas · NCT07564232

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.