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Study on the Treatment of Warthin’s Tumor with Bleomycin Sclerotherapy for Patients with Warthin’s Tumor

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What is this study about?

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.

1 joining the study

Participation begins after confirming the diagnosis of Warthin’s tumor through specific tests such as FNAB (fine needle aspiration biopsy), CNAB (core needle aspiration biopsy), and MRI (magnetic resonance imaging).

Eligibility requires a desire for non-surgical treatment and meeting certain health criteria, including adequate kidney function and age of 18 or older.

2 treatment administration

The treatment involves the use of Bleomycin Baxter 15 000 KY, a solution for injection or infusion.

The medication is administered directly into the tumor using a method called intralesional use, guided by ultrasound to ensure accuracy.

3 monitoring and follow-up

The primary goal is to observe changes in the tumor’s volume and symptoms at 6 and 12 months after the treatment.

Regular follow-up appointments are scheduled to monitor progress and assess the effectiveness and safety of the treatment.

4 completion of the study

The study is expected to conclude by June 1, 2027, with all data collected and analyzed to determine the treatment’s success.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hbxfprch Umtmcydtrw Cpxfgdp Hjtznhxi Helsinki Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Not yet recruiting
21.09.2021

Trial locations

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.

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 ID:
2024-518794-33-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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