A study on the use of a hydrogel during breast conserving surgery to improve precision of targeting and positioning of breast irradiation.

Pilot study on the use of a radiopaque hydrogel during breast conserving surgery with full-thickness closure for target definition and positioning of boost or partial breast irradiation.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28313

Enrollment

Registered

2017-06-27

Start date

2017-07-17

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

breast cancer, irradiation, hydrogel, target definition, positioning, mammacarcinoom, bestraling, hydrogel, doeldefinitie, positionering

Interventions

3-10ml of Iodined PolyEthyleneGlycol, brandname “TraceIT” will be left behind just before FTC by stepwise instillation and coating the lumpectomy cavity walls. All patients will undergo a CT at 3 time

Eligibility

Inclusion criteria

Inclusion criteria: • Woman • Undergoing breast conserving surgery • Indication for radiotherapy • Full thickness closure (level 1 oncoplastic breast surgery) planned • Written informed consent

Exclusion criteria

Exclusion criteria: • Oncoplasty technique (level 2 Oncoplastic breast surgery) planned • Node positive (pre-operatively diagnosed) • Allergy for PEG • Allergy for Iodine • Radiotherapy planned in other hospital than Erasmus MC

Design outcomes

Primary

Measure	Time frame
the Conformity Index (Cx) of target definition.	—

Secondary

Measure	Time frame
the distance between observers’ target volumes (dCOM), target volumes, Cavity Visualisation Score, feasibility of the hydrogel marker instillation, stability of the hydrogel marker volume over time, adverse events, ease of use, motion of hydrogel marker/clips over time, the feasibility of patient positioning based on the hydrogel marker on cone beam computed tomography (CBCT) and planar kV images and the accuracy of this procedure compared to positioning based on the surgical clips.	—

Measure

Time frame

the distance between observers’ target volumes (dCOM), target volumes, Cavity Visualisation Score, feasibility of the hydrogel marker instillation, stability of the hydrogel marker volume over time, adverse events, ease of use, motion of hydrogel marker/clips over time, the feasibility of patient positioning based on the hydrogel marker on cone beam computed tomography (CBCT) and planar kV images and the accuracy of this procedure compared to positioning based on the surgical clips.

—

Contacts

Public ContactGerson M. Struik

Kleiweg 500

g.struik@franciscus.nl0031104616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)