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


- candidate number27468
- NTR NumberNTR6610
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-jun-2017
- Secondary IDsMEC-2017-283 METC Erasmus MC ABR: NL61639.078.17
- Public TitleA study on the use of a hydrogel during breast conserving surgery to improve precision of targeting and positioning of breast irradiation.
- Scientific TitlePilot 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.
- ACRONYMTarget Study
- hypothesisWe hypothesize that instillation of a radiopaque hydrogel before full thickness closure of the lumpectomy cavity will reduce inter-observer variability during target definition and improve patient setup accuracy for boost or partial breast irradiation.
- Healt Condition(s) or Problem(s) studiedMamma carcinoma, Radiation, Hydrogel
- Inclusion criteria• Woman
• Undergoing breast conserving surgery
• Indication for radiotherapy
• Full thickness closure (level 1 oncoplastic breast surgery) planned
• Written informed consent
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 17-jul-2017
- planned closingdate1-jan-2018
- Target number of participants20
- Interventions3-10ml 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 times (post-op (day of surgery), 4 weeks (regular planning CT), and 2.5± 0.5months).

Cross sectional study, with a retrospective matched control group, on the inter-observer variability of 6 measures applied to 60 patients across 5 observers. All 5 observers will rate all 60 patients. Interventional group of 20 patients will get hydrogel + clips. Matched control group of 40 patients gets standard clips only. The positioning accuracy will be assessed in a subset of 10 patients from the intervention group. Study will be performed combined in a large secondary hospital (Franciscus Gasthuis, Rotterdam) and a tertiary hospital (Erasmus MC, Rotterdam)
- Primary outcomethe Conformity Index (Cx) of target definition.
- Secondary outcomethe 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.
- Timepointssurgery (intervention)
post-op CT-scan (CT1) at day of Surgery
planningsCT (CT2) at +/- 1 month
follow-up CT (CT3) at +/- 2.5 months
- Trial web sitenot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Gerson M. Struik
- CONTACT for SCIENTIFIC QUERIES Gerson M. Struik
- Sponsor/Initiator Erasmus MC - Cancer Institute
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center - Cancer Institute, Augmenix (traceIT gel system)
- Publications-
- Brief summarySUMMARY
Rationale: Breast conserving surgery (BCS) followed by breast radiotherapy has been shown to be as effective as ablative therapy in the treatment of early stage breast cancer patients. In BCS there is a shift towards the use of full-thickness closure (FTC), or oncoplastic techniques in general. This development creates challenges in breast radiotherapy target definition. Quality of target definition for radiotherapy after FTC is imprecise. We hypothesize that instillation of a radiopaque hydrogel during FTC of the lumpectomy cavity will reduce inter-observer variability during target definition for boost or partial breast irradiation. Also, we hypothesize that it will increase the accuracy of patient positioning during radiation delivery.
Objective: Primary objective: Estimate the Conformity Index (Cx) of target definition. Secondary objectives: Estimate the distance between the center of mass (dCOM) of the observers’ target volumes, Cavity Visualisation Score (CVS), feasibility of the hydrogel marker instillation, stability of the hydrogel marker volume over time, comparison of target volumes defined by clips and hydrogel, 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) made on a conventional linac and planar kV images made on a Cyberknife and the accuracy of these procedures compared to positioning based on the surgical clips.
Study design: Cross sectional study, with a retrospective matched control group, on the inter-observer variability of 6 measures applied to 60 patients across 5 observers. All 5 observers will rate all 60 patients. Interventional group of 20 patients will get hydrogel + clips. Matched control group of 40 patients gets standard clips only. The positioning accuracy will be assessed in a subset of 10 patients from the intervention group. Study will be performed combined in a large secondary hospital (Franciscus Gasthuis, Rotterdam) and a tertiary hospital (Erasmus MC, Rotterdam)
Study population: Women undergoing breast conserving surgery for breast cancer and/or ductal carcinoma in situ (DCIS) with an indication for radiotherapy where full thickness closure (level 1 oncoplastic breast surgery) is planned. Patients with mammoplasty technique (level 2 Oncoplastic breast surgery) planned, positive lymph nodes diagnosed pre-operatively or known allergies for PEG/Iodine are excluded.
Intervention (if applicable): 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 times (post-op (day of surgery), 4 weeks (regular planning CT), and 2.5± 0.5months).
Main study parameters/endpoints: primary endpoint: the Conformity Index (Cx) of target definition. 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 and the accuracy of this procedure compared to positioning based on the surgical clips.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Tolerance of the investigational product is expected to be good based on existing safety data. Radiation dose of the extra study images is negligible with regards to total radiation dose of the radiotherapy treatment. Furthermore, target definition and patient positioning may be improved by this new technique, with possibly lower radiation dose to healthy tissue and fewer geographical misses. We conclude that the benefits of the treatment when used as intended considerably outweigh the risks.
- Main changes (audit trail)
- RECORD27-jun-2017 - 13-aug-2017


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