SHARP trial - Stereotactic Heart Ablative RadiotheraPy Prospective observational study of MR-guided stereotactic ablative radiotherapy of inoperable primary or recurrent malignant cardiac sarcomas or cardiac metastases

SHARP trial - Stereotactic Heart Ablative RadiotheraPy Prospective observational study of MR-guided stereotactic ablative radiotherapy of inoperable primary or recurrent malignant cardiac sarcomas or cardiac metastases - SHARP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027108

Enrollment

Registered

2021-11-08

Start date

2022-01-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C38 C79.84

Interventions

Group 1: Multicenter single-arm observational study of patients who will receive MR-guided stereotactic ablative radiotherapy for unresectable primary or recurrent malignant cardiac sarcomas or cardia

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All of the following criteria must be met at the time of registration: 1. Patient must be able to comply with the study protocol and provide informed consent 2. Age =18 years 3. inoperable primary or recurrent malignant cardiac sarcomas or cardiac metastases, or patients who decline surgery 4. ECOG Performance Status: 0-2

Exclusion criteria

Exclusion criteria: None of the following criteria may be present at the time of registration: 1. Patients without legal capacity or unable to understand the nature, significance and consequences of the study 2. Simultaneous participation in other interventional trials which could interfere with this trial and/or participation before the end of a required restriction period 3. Pregnancy 4. Exclusion criteria for MRI (e.g. non-MRI conditional pacemaker or ICD, implants)

Design outcomes

Primary

Measure	Time frame
Feasibility and safety of online adaptive MR-guided SBRT in cardiac/epicardial/paracardial lesions. The primary endpoint is a combined endpoint where the occurrence of any of the following events is considered an event: 1. Any acute toxicity = grade 3 within 3 months after RT initiation (assessed according to CTCAE version 5.0) 2. Therapy discontinuation, whereby a connection with the treatment must exist 3. Mortality within 3 months after RT start (related to treatment and/or disease).	—

Measure

Time frame

Feasibility and safety of online adaptive MR-guided SBRT in cardiac/epicardial/paracardial lesions. The primary endpoint is a combined endpoint where the occurrence of any of the following events is considered an event: 1. Any acute toxicity = grade 3 within 3 months after RT initiation (assessed according to CTCAE version 5.0) 2. Therapy discontinuation, whereby a connection with the treatment must exist 3. Mortality within 3 months after RT start (related to treatment and/or disease).

—

Secondary

Measure	Time frame
1. Oncologic outcome including local control and survival outcome 2. Acute and late toxicity 3. Patient reported outcome 4. Technical feasibility of treatment (intrafractional image quality and gating [ability to track the lesion or surrogate], frequency of plan adaptation, motion analysis, duty cycle of respiratory gating, physical assessment of treatment plans.	—

Countries

Germany, Italy, Switzerland

Contacts

Public ContactStefanie Corradini

Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LMU

Stefanie.Corradini@med.uni-muenchen.de+4989440073770

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026