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.

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. - Target study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47859

Enrollment

Registered

2017-06-20

Start date

2017-07-18

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

breast cancer breast carcinoma

Interventions

5-10ml 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 ti

Eligibility

Age

18 Years to 99 Years

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 * need for adjuvant chemotherapy * Allergy for PEG * Allergy for Iodine

Design outcomes

Primary

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

Secondary

Measure	Time frame
Secondary endpoints: 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 made on a conventional linac and a Cyberknife and the accuracy of this procedure compared to positioning based on the surgical clips.	—

Measure

Time frame

Secondary endpoints: 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 made on a conventional linac and a Cyberknife and the accuracy of this procedure compared to positioning based on the surgical clips.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)