Is NCT06447103 recruiting in Los Angeles, CA?

Yes, NCT06447103 is currently recruiting participants at its Los Angeles, CA location. This clear cell renal cell carcinoma clinical trial is actively enrolling qualified participants.

How do I join the clear cell renal cell carcinoma clinical trial in Los Angeles?

To join this clinical trial in Los Angeles, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Los Angeles clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Clear Cell Renal Cell Carcinoma Clinical Trial in Los Angeles, CA

About This Clear Cell Renal Cell Carcinoma Study in Los Angeles

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.

Sponsor: Jonsson Comprehensive Cancer Center

Who Can Participate

Inclusion Criteria

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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Los Angeles?

Yes, this clinical trial (NCT06447103) has an active research site in Los Angeles, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Clear Cell Renal Cell Carcinoma Treatment Options in Los Angeles, CA

If you're searching for clear cell renal cell carcinoma treatment options in Los Angeles, CA, this clinical trial (NCT06447103) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Los Angeles research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced clear cell renal cell carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all clear cell renal cell carcinoma clinical trials near you to find additional studies recruiting in your area.

Clear Cell Renal Cell Carcinoma Clinical Trial in Los Angeles, CA

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