MELODYRecruiting

Comparison of Various Imaging Techniques for the Safe Removal of Breast Cancer

Gender
Women and men
Age
18 years and older
Trial type
Observational
Line of therapy
all
Phase

What is this trial about?

Surgical removal of the tumor is a key component of breast cancer treatment. The goal is usually breast-conserving therapy (BCT). Since complete removal of the tumor is crucial for the prognosis, various imaging techniques—such as ultrasound—are used before and during surgery to ensure the highest possible level of certainty. The goal of the MELODY study is to compare the effectiveness of these various imaging techniques and to assess the extent to which they enable the complete removal of tumor tissue. The study is not testing a new drug or therapy. Women and men aged 18 and older who have breast cancer and are scheduled to undergo breast-conserving surgery (BCS) are eligible to participate in the study.

Trial flow

Requirements

Diagnosis: breast cancer

Age: 18 years and older

Line of therapy: Unabhängig von Therapielinie

Key inclusion criteria: Breast-conserving surgery (BCS); women and men; classification into cohorts according to tumour marking method

Allocation

Stratifizierung anhand von Markern

Treatment

Wire-guided Localization
Intraoperative Ultrasound
Magnetic Localization
Radar Reflector Localization
Radiofrequency Localization
Radioactive Localization
Ink Localization
Luminomark Localization

Follow-up

24 months

Detailed description

Breast cancer (mammary carcinoma) is one of the most common cancers among women. The choice of treatment depends on various factors. An essential component of modern treatment regimens is the removal of the tumor from the breast, with the goal of preserving the breast (breast-conserving therapy) whenever possible. Complete removal of the tumor is crucial for a favorable prognosis, ensuring that no malignant tissue remains in the body. However, this is not always easy, and if the tumor is not completely removed, a second surgery may be necessary, which places an additional burden on patients. To ensure complete tumor removal, various imaging techniques are now used before or during surgery to mark the tumor tissue or assess the tissue structure during the procedure. There are about eight different techniques, but so far, none of them has been clearly identified as superior.

The goal of the MELODY study is to compare the effectiveness of these various imaging techniques. In particular, the study examines whether the tumor can be completely removed and what the probability is of needing a repeat surgery. The study is purely observational; no new technique is being tested, nor is any specific method mandated—the choice of technique is left to the treating physicians. Patients will be monitored for a period of two years following surgery to assess the long-term success rate.

Individuals who wish to participate in this study must be at least 18 years old and have breast cancer for which breast-conserving surgery is planned. Both women and men are eligible to participate. Patients who require a mastectomy—that is, complete removal of the breast—as their first surgery, or who cannot undergo surgery for medical reasons, are not eligible to participate. The study is being conducted at several hospitals and follows a prospective approach, meaning that patients are observed over an extended period to assess the long-term advantages and disadvantages of the various procedures.

Facts

  1. What condition: Breast cancer (breast carcinoma)
  2. Cancer characteristics: Breast cancer to be treated with breast-conserving surgery
  3. What the study examines: Comparison of tumor marking methods before and during surgery
  4. Study objective: To evaluate the effectiveness and patient satisfaction with various imaging techniques
  5. How long will the study last: Two-year observation period
  6. Study characteristics: An observational study with multiple arms comparing different techniques. No new imaging techniques are being tested

Trial sites

19 trial sites in Germany are listed. Find a site near you.

  • Klinikum St. Marien Amberg

    Mariahilfbergweg 7, 92224 Amberg, Oberpfalz

    Recruiting
  • Universitätsklinikum Augsburg

    Stenglinstraße 2, 86156 Augsburg

    Recruiting
  • Caritas-Krankenhaus Bad Mergentheim

    Uhlandstraße 7, 97980 Bad Mergentheim

    Recruiting
  • Universitätsklinikum Bonn

    Venusberg-Campus 1, 53127 Bonn

    Recruiting
  • Universitätsklinikum Düsseldorf

    Moorenstr. 5, 40225 Düsseldorf

    Recruiting
  • AGAPLESION Frankfurter Diakonie Kliniken gGmbH

    Frankfurt am Main

    Recruiting

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description is based on the public trial registry (NCT05559411) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.