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A radiopaque hydrogel to improve target definition of boost or partial breast irradiation in patients with low cavity visualization scores

A radiopaque hydrogel to improve target definition of boost or partial breast irradiation in patients with low cavity visualization scores - Target-2 study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46264
Enrollment
20
Registered
2018-11-21
Start date
2018-06-01
Completion date
Unknown
Last updated
2024-04-15

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

The intervention will be performed under sterile conditions and, if needed, with local anesthesia of the skin using lidocaine 1% (max 5cc). 2-4 ml of Iodined PolyEthyleneGlycol, brandname *TraceIT*

Sponsors

Sint Franciscus Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women following breast conserving surgery for breast cancer and/or ductal carcinoma in situ (DCIS) with an indication for boost or partial breast radiotherapy according to local protocol of the Erasmus MC. CVS score 1-3 on original CT-planning for radiotherapy. written informed consent

Exclusion criteria

Exclusion criteria: Oncoplastic technique (level 2: volume replacement) performed Patients with known allergies for PEG or Iodine No surgical scar visible / post-operative effects visible on US

Design outcomes

Primary

MeasureTime frame
Primary endpoint: the Conformity Index (Cx) of target definition.

Secondary

MeasureTime frame
Secondary endpoints: the distance between observers* target volumes (dCOM), target volumes, Cavity Visualisation Score, feasibility of the hydrogel marker injection, stability of the hydrogel marker volume over time, adverse events, ease of use, motion of hydrogel marker/clips over time, feasibility of using the hydrogel for patient positioning and comparison of dose to organs at risk for treatment plans with and without hydrogel.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)