Helsinki University Central Hospital
Helsinki, Finland
Not yet recruitingPapillary cystadenoma lymphomatosum
Study on the Treatment of Warthin's Tumor with Bleomycin Sclerotherapy for Patients with Warthin's Tumor
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the treatment of Warthin's tumor, a type of benign growth that typically occurs in the salivary glands. The treatment being investigated is called bleomycin sclerotherapy. Sclerotherapy is a procedure where a solution is injected into the tumor to shrink it. In this study, the solution used is bleomycin sulfate, which is administered through an injection guided by ultrasound, a technique that uses sound waves to create images of the inside of the body.
The purpose of the study is to examine how effective and safe this treatment is for patients with Warthin's tumor. Participants in the study will receive the bleomycin treatment and will be monitored over time to see how the size of the tumor changes and how symptoms improve. The study will track these changes at 6 and 12 months after the treatment is given. This approach aims to provide a non-surgical option for managing Warthin's tumor, which may be preferred by some patients.
Throughout the study, participants will undergo regular check-ups to assess the progress of the treatment. The study is designed to gather information on the natural course of the tumor when treated with bleomycin sclerotherapy, offering insights into its potential as a standard treatment option in the future.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
7 criteria
- The patient must have a **Warthin's tumor**, which is a type of growth, diagnosed by specific tests like **FNAB** (Fine Needle Aspiration Biopsy), **CNAB** (Core Needle Aspiration Biopsy), and **MRI** (Magnetic Resonance Imaging).
- The patient should prefer a non-surgical treatment option.
- The tumor must be confirmed by a specialist pathologist who is experienced with head and neck tumors.
- The patient must be able to undergo an MRI scan.
- The patient must be at least 18 years old.
- The patient's kidney function should not be significantly reduced, meaning a **GFR** (Glomerular Filtration Rate) greater than 50 ml/min is required. GFR is a test to check how well the kidneys are working.
- The tumor must be located in the **parotid gland**, which is a salivary gland near the ear.
Who cannot join the trial?
3 criteria
- Individuals who are not diagnosed with Warthin's tumor cannot participate. Warthin's tumor is a type of growth that usually occurs in the salivary glands.
- Participants must be within the specified age range, which is not detailed here, but typically means certain age groups are excluded.
- People who are part of a vulnerable population, such as those who might not be able to give informed consent, are not eligible.
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Investigated drugs
Bleomycin is a medication used in this clinical trial to treat Warthin's tumor. It is administered through a procedure called sclerotherapy, which involves injecting the medication directly into the tumor. The goal of using bleomycin in this trial is to evaluate its effectiveness and safety in reducing or eliminating the tumor when guided by ultrasound.
What is already known about the treatment
Bleomycin – Bleomycin is administered through injection, often guided by ultrasound for precise application. It is currently being studied for its effectiveness and safety in treating Warthin's tumor, a benign salivary gland tumor. The medication works by causing DNA strand breaks, which leads to cell death, making it useful in targeting tumor cells. Bleomycin is classified as an antineoplastic antibiotic, commonly used in cancer treatment.
Investigated diseases
Warthin's tumor – Warthin's tumor is a benign growth that typically occurs in the salivary glands, most often in the parotid gland. It is characterized by a slow-growing, painless mass that may feel firm or rubbery to the touch. The tumor is composed of both epithelial and lymphoid tissue, giving it a unique appearance under a microscope. Although it is non-cancerous, it can sometimes be mistaken for other types of salivary gland tumors due to its similar presentation. Warthin's tumor is more common in older adults and has a higher prevalence in males. It is not known to spread to other parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518794-33-00Estimated enrolment100 patientsSponsorHUS-yhtymae
sourced from the EU Clinical Trials Register and site verification
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