Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer

Q: Who can participate in NCT04473781?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT04473781?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Prospective Study of Interstitial Brachytherapy for Unresectable/Unablatable T1b/T2a Renal Masses

Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer (NCT04473781) is a Phase 1 interventional studying Stage I Renal Cell Cancer and Stage II Renal Cell Cancer, sponsored by Jonsson Comprehensive Cancer Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This phase I/II trial investigates the side effects of interstitial brachytherapy and to see how well it works in limiting the growth of large kidney cancer masses in patients with kidney cancer that have refused or are unable to undergo surgery or ablation (unresectable/unablatable). Brachytherapy, also known as internal radiation therapy, temporarily introduces a radiation source into or near the tumor to eradicate the tumor cells. Giving brachytherapy may potentially reduce the size of the kidney cancer mass that would otherwise not be amenable to surgical management and translate into lower risk of spread.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Stage I Renal Cell Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 17 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Elected to undergo interstitial brachytherapy as part of conventional treatment for renal cell carcinoma - Biopsy proven renal cell carcinoma - No definitive evidence of locally advanced (nodal or tumor thrombus) or distant (metastatic) disease - Lesion size (maximal dimension) of 4 to 10 cm - Patient not a candidate for curative surgery (unwilling or unable to pursue surgery) - Lesion cannot be reliably treated with ablative techniques - Entire lesion able to be treated adequately by brachytherapy per radiation oncologist - Tumor predominantly solid (\~ \> 80%) - Lesion that has been observed for \>= 6 months with demonstrable growth rate anticipated to be \>= 4 mm/year by same imaging modality - Renal tumor that is amenable to percutaneous access for interstitial renal brachytherapy (Institutional Review Board \[IRB\]) - Hemoglobin \> 9 - Absolute neutrophil count (ANC) \>= 1500/uL (microliter) - Platelets \>= 100,000/uL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 upper limit of normal (ULN) - Total bilirubin =\< ULN - A competent immune system - Estimated glomerular filtration rate (eGFR) \>= 30 - Good performance status (Eastern Cooperative Oncology Group \[ECOG\]) \< 2 - Understanding and willingness to provide consent - No prior systemic treatment for kidney cancer - Women of childbearing potential must have negative pregnancy test at start of therapy Who Should NOT Join This Trial: - Presence of an active, untreated, non-renal malignancy - Uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction within 6 months - History of bleeding diathesis or recent bleeding episode - Need for urgent treatment of renal cancer due bleeding, pain, or paraneoplastic syndrome - Prior surgery or radiation therapy to the operative site - Unwillingness to undergo clinical and laboratory monitoring and/or imaging studies Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Elected to undergo interstitial brachytherapy as part of conventional treatment for renal cell carcinoma * Biopsy proven renal cell carcinoma * No definitive evidence of locally advanced (nodal or tumor thrombus) or distant (metastatic) disease * Lesion size (maximal dimension) of 4 to 10 cm * Patient not a candidate for curative surgery (unwilling or unable to pursue surgery) * Lesion cannot be reliably treated with ablative techniques * Entire lesion able to be treated adequately by brachytherapy per radiation oncologist * Tumor predominantly solid (\~ \> 80%) * Lesion that has been observed for \>= 6 months with demonstrable growth rate anticipated to be \>= 4 mm/year by same imaging modality * Renal tumor that is amenable to percutaneous access for interstitial renal brachytherapy (Institutional Review Board \[IRB\]) * Hemoglobin \> 9 * Absolute neutrophil count (ANC) \>= 1500/uL (microliter) * Platelets \>= 100,000/uL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 upper limit of normal (ULN) * Total bilirubin =\< ULN * A competent immune system * Estimated glomerular filtration rate (eGFR) \>= 30 * Good performance status (Eastern Cooperative Oncology Group \[ECOG\]) \< 2 * Understanding and willingness to provide consent * No prior systemic treatment for kidney cancer * Women of childbearing potential must have negative pregnancy test at start of therapy Exclusion Criteria: * Presence of an active, untreated, non-renal malignancy * Uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction within 6 months * History of bleeding diathesis or recent bleeding episode * Need for urgent treatment of renal cancer due bleeding, pain, or paraneoplastic syndrome * Prior surgery or radiation therapy to the operative site * Unwillingness to undergo clinical and laboratory monitoring and/or imaging studies

Treatments Being Tested

PROCEDURE

Interstitial Radiation Therapy

Undergo interstitial brachytherapy

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04473781), the sponsor (Jonsson Comprehensive Cancer Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04473781 clinical trial studying?

Who can participate in NCT04473781?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04473781?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04473781. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04473781. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.