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Enrolling by Invitation

NCT Number: NCT07030231

Use of Intraoperative Radiotherapy in Breast Cancer

The Utility of Intraoperative Radiotherapy in Breast Cancer (RIOMA) is an observational project to understand the use and outcomes of intraoperative radiotherapy in patients with breast cancer under conditions of clinical use (not clinical trials). Intraoperative radiotherapy (IORT) is a technique that began to be used years ago, transferring the patient from the operating room to the radiotherapy suite. This technique therefore fell into disuse. The emergence of miniaturized linear accelerators has led to a resurgence of IORT, especially as part of conservative treatment in patients with breast cancer, both as a booster or as a sole treatment (partial breast irradiation).

This project is based on an online platform. Each participating center will be assigned access codes on the website to access and complete the coded clinical data for each patient treated with intraoperative radiotherapy. Data on tumor characteristics, the type of intraoperative radiotherapy, follow-up, complications, and cosmetic outcomes are included.

Primary objective:

To understand the characteristics of patients treated with intraoperative radiotherapy under routine clinical practice conditions.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital del Mar

Barcelona, 08003, Spain

About this study

The project is based on structured data collection in an electronic data collection notebook (using the OpenclinicaTM standard), relating to the care provided according to standard clinical practice in the Radiation Oncology, Gynecology and Surgery departments of the participating centers in Spain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with breast cancer who are candidates for intraoperative irradiation exclusively
  • Patients with breast cancer who are candidates for intraoperative irradiation combined with external beam irradiation
  • Patients with recurrence of breast cancer who are candidates for intraoperative irradiation
  • Have read the information sheet and signed the informed consent form -

Exclusion criteria

  • Patient's that express wish not to participate.

Treatment and study plan

Intraoperative

Radiation

Intraoperative radiotherapy with any device after conservative surgery in early breast cancer

Primary outcomes

  1. Characteristics of patients treated with intraoperative radiotherapy according to the conditions of standard clinical practice,

    Time frame: From enrollement to the end of recruitment at 10 years

    To evaluate the characteristics of patients treated with intraoperative radiotherapy according to the conditions of standard clinical practice, retrospectively from the beginning of the implementation of the technique and prospectively from the launch of this registry.

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

Utilización de la Radioterapia IntraOperatoria en la Neoplasia de MAma

Acronym: RIOMA

Important dates

Study start
2020
Primary completion
2030
Study completion
2031
First posted
Jun 22, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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