Ongoing Clinical Trials for Papillary Cystadenoma Lymphomatosum
Currently, there is 1 ongoing clinical trial investigating treatment options for Papillary Cystadenoma Lymphomatosum (also known as Warthin’s tumor). This trial is exploring a non-surgical approach using bleomycin sclerotherapy, offering an alternative for patients who prefer to avoid surgery.
Clinical trial locations
Study on the Treatment of Warthin’s Tumor with Bleomycin Sclerotherapy for Patients with Warthin’s Tumor
This clinical trial is investigating bleomycin sclerotherapy as a treatment option for Warthin’s tumor, a benign growth that typically develops in the salivary glands, particularly the parotid gland near the ear. The study aims to provide a non-surgical alternative for managing this condition.
Main inclusion criteria:
- Confirmed diagnosis of Warthin’s tumor through specific tests including fine needle aspiration biopsy (FNAB), core needle aspiration biopsy (CNAB), and MRI imaging
- Age 18 years or older
- Preference for non-surgical treatment
- Adequate kidney function with a glomerular filtration rate (GFR) greater than 50 ml/min, which measures how well the kidneys are working
- Ability to undergo MRI scanning
- Tumor located in the parotid gland
- Diagnosis confirmed by a specialist pathologist experienced with head and neck tumors
Main exclusion criteria:
- Absence of confirmed Warthin’s tumor diagnosis
- Individuals outside the specified age range
- Vulnerable populations who cannot provide informed consent
Focus and goals:
The study focuses on evaluating the effectiveness and safety of bleomycin sclerotherapy as a treatment for Warthin’s tumor. Sclerotherapy involves injecting a solution directly into the tumor to shrink it. In this trial, the solution used is bleomycin sulfate, which is administered through ultrasound-guided injection. Ultrasound imaging helps doctors accurately target the tumor using sound waves to create real-time images of the treatment area.
The primary goal is to observe changes in tumor size and improvement in symptoms at 6 and 12 months after treatment. Participants will receive regular follow-up appointments to monitor their progress and assess how well the treatment is working. This approach offers a non-surgical option that may be preferred by patients who wish to avoid traditional surgery.
Investigational drug:
The medication being studied is bleomycin, specifically Bleomycin Baxter 15,000 KY. Bleomycin is classified as an antineoplastic antibiotic and works by causing DNA strand breaks in cells, leading to cell death. This mechanism makes it effective in targeting tumor cells. In this trial, bleomycin is injected directly into the tumor using a procedure guided by ultrasound for precise application. The study will evaluate both the effectiveness and safety of this medication when used to treat Warthin’s tumor.
Summary
Currently, only one clinical trial is actively investigating treatment options for Papillary Cystadenoma Lymphomatosum, also known as Warthin’s tumor. This trial is being conducted in Finland and focuses on a minimally invasive approach using bleomycin sclerotherapy as an alternative to surgical removal. The study is particularly notable for offering patients who prefer non-surgical options a potential new treatment pathway. The trial is expected to conclude by June 2027, with results that may help establish bleomycin sclerotherapy as a standard treatment option for this benign salivary gland tumor in the future.
