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Towards implementation of on-line MRI-guided radiation therapy in breast cancer patients

Towards implementation of on-line MRI-guided radiation therapy in breast cancer patients - TIMBRE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47005
Enrollment
50
Registered
2016-06-01
Start date
2016-12-19
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

breast cancer breast malignancy

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female gender; - *18 years old; - Patients with cTis-4N0-3M0-1 breast cancer (before any treatment) or with pTis-4N0-3M0-1 breast cancer (postoperatively); - Written informed consent provided.;Additional inclusion criterion for the MRI regional lymph nodes imaging arm and RT planning CT scan: - Positive lymph nodes based on standard diagnostic ultrasound-guided fine needle aspiration. - Tumor positive axillary lymph nodes on standard diagnostic FDG-PET scan: o For preoperative study participation: on FDG-PET scan before start of any treatment; o For postoperative study participation: on FDG-PET after neoadjuvant systemic therapy if neoadjuvant systemic therapy was given.

Exclusion criteria

Exclusion criteria: - Legal incapacity; - MRI exclusion criteria of the MRI safety group of Radiology (UMC Utrecht); - Previously known inability to undergo the scanning procedure.;Additional exclusion criterion for patients in the regional lymph nodes imaging arm: - Previous ALND and/or surgery of the supraclavicular region.;Additional exclusion criterion for patients in the breast imaging arm: - Breast tumor > 3 cm; - For postoperative study participation: large seroma volume during physical examination and/or on standard RT planning CT.

Design outcomes

Primary

MeasureTime frame
1) Develop optimal MRI-sequences and an on-line adaptive MRI-only treatment planning workflow. 2) Investigate the feasibility of delineating tumor positive lymph nodes on MRI registered with the standard diagnostic FDG-PET scan and standard RT planning CT scan, compared to delineation based on standard RT planning CT scan and standard diagnostic FDG-PET scan.

Secondary

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)