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Prospective study comparing 2 immobilization devices for radiotherapy in breast cancer patients (Position Study)

Prospective study comparing vacuum bag vs inclined breast board for Inv-IMRT in breast cancer patients (Position Study) - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/102873
Enrollment
50
Registered
2026-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: Nil: Nil Intervention2: Breast Board Immobilization Device: Plans will be made on the simulation scan of Patient in supine position on a Vacuum bag and compared with that on the Breast

Sponsors

Tata Memorial Centre Mumbai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 All non-metastatic breast cancer patients planned for adjuvant breast RT and require planning with Inv-IMRT technique 2 Patients who can lay supine both on a Vacuum bag and a Breast board

Exclusion criteria

Exclusion criteria: 1 Patients who require custom support due to anatomical or functional limitations and considered not suitable for immobilization on Breast board 2 Patients planned for prone position RT

Design outcomes

Primary

MeasureTime frame
1.To compare the average of daily set-up errors all six directions (anterior, posterior, superior, inferior, and left and right)Timepoint: Set-up errors will be noted during all treatment days (Day1 to Day 15). Average setup error in each direction will be calculated for comparison between 2 immobilization devices

Secondary

MeasureTime frame
Compare the average of the daily patient comfort rating measured using a 5-point Likert scale between patients immobilized on the BB vs VB for Inv-IMRTTimepoint: Day of simulation and subsequently on all treatment days;2. Evaluate factors affecting comfort of the patient on BB vs VB positionTimepoint: At the end of treatment;3. Evaluate differences in mean target and OAR volumes between the BB vs VB scanTimepoint: At the end of plan finalization;4. Compare mean number of optimizations needed for generating a clinically acceptable Inv-IMRT plan on a BB vs VBTimepoint: At the end of plan finalization;5. To evaluate PTV coverage metrics, homogeneity and conformity between the BB vs VB planTimepoint: At the end of plan finalization during analysis;6. Evaluate dosimetric differences in the OAR doses between Inv-IMRT plans made for patients on a BB vs VBTimepoint: At the end of plan finalization during analysis;7. Compare average of the daily time taken for set-up between patients immobilized on the BB vs VB for Inv-IMRTTimepoint: On all days during radiotherapy;8. Record any instances/ near-misses of gantry head hitting the couch/ patient when planned with a BBTimepoint: On all days during radiotherapy;9. Evaluating PTV margin needed using Van-Herk s, Stroom s and ICRU62 formulaTimepoint: At the end of treatment during analysis

Countries

India

Contacts

Public ContactRima Sanjay Pathak

Tata Memorial Centre

drrimapathak@gmail.com9969474000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026