PERSBRA: Evaluation of the Feasibility of Developing Personalized Breast Cancer Radiotherapy Assistive Device With 3D Printing
Study Details
Study Description
Brief Summary
Breast cancer is the most common malignancy among women worldwide. For early stage breast cancer, adjuvant radiotherapy is essential to minimize loco-regional disease recurrence. However, significant portions of the heart and the lungs are exposed to low dose radiation during radiotherapy, which result in stochastic side effects among breast cancer survivors. Inspired by 3D printing technology, we approached this issue with an in-house made PERSonalized BReAst holder system (PERSBRA). PERSBRA is composed of a 3D-printed plastic holder covering the whole breast and an air-filled interface. Its main function is to reproducibly adjust the breast position to decrease heart and lung radiation exposure in tangential fields. Here we propose to measure the performance of PERSBR in terms of radiation dosimetry in 50 patients receiving scheduled whole breast irradiation. For customized PERSBRA, body shape of the patient with or without a bustier corset will be captured with a handheld 3D scanner and input into a 3D printer for PERSBRA design and manufacturing. A participant will receive two more CT scans in addition to the simulation scan with PERSBRA in place before the first and the sixth fractions of irradiation. These images will be analyzed for dosimetric parameters in the presence/absence of PERSBRA as well as position reproducibility. The data will provide proof-of-principle evidence for the clinical utility of PERSBRA and will facilitate its further refinement.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Wear Personalized breast holder system (PERSBRA) to receiving radiotherapy Wear PERSBRA to the end of radiotherapy. |
Device: PERSBRA
After the patient is in the semi-prone position, the body shape and breast position images are obtained by the stereo scanning technology, and then using 3d printing technology to print PERSBRA.
PERSBRA maintain a favorable new breast position in the supine position during routine radiotherapy, the cardiopulmonary dose during radiotherapy can be reduced by wearing PERSBRA.
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Outcome Measures
Primary Outcome Measures
- Irradiated cardiac dose [Time Frame: At simulation, expected average of 1 week]
Radiation dose distribution of the cardiopulmonary on the affected side.
Secondary Outcome Measures
- Irradiated dose of left anterior descending artery [Time Frame: At simulation, expected average of 1 week]
Radiation dose distribution of the left anterior descending artery on the affected side.
- Irradiated lung dose [At simulation, expected average of 1 week]
Radiation dose distribution of the lung on the affected side.
- Clinical target volume [At simulation, expected average of 1 week]
Radiation dose distribution of clinical target volume.
- Irradiated dose of axillary lymphatic area [At simulation, expected average of 1 week]
Irradiated dose of axillary lymphatic area.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with early breast cancer or carcinoma in situ after partial mastectomy have decided to receive adjuvant radiation therapy for the breast on the affected side, and use non-contrast computed tomography to obtain localized images is part of the original treatment plan.
Exclusion Criteria:
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Clinical diagnosis or pathological diagnosis has lymph node metastasis, lymph node micrometastasis, or lymph node tumor cells.
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The clinical diagnosis is likely to have metastatic cancer.
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Pregnant women.
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Be younger than 20 years old.
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The subject was unable to read and understand the subject consent form written in Chinese and complete the informed consent procedure.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taipei Medical University Hospital | Taipei | Taiwan |
Sponsors and Collaborators
- Taipei Medical University Hospital
Investigators
- Study Director: Long-Sheng Lu, MD, Ph.D., Taipei Medical University Hospital
- Study Chair: Jeng-Feng Chiou, MD, Ph.D., Taipei Medical University Hospital
Study Documents (Full-Text)
More Information
Publications
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- Deasy JO, Bentzen SM, Jackson A, Ten Haken RK, Yorke ED, Constine LS, Sharma A, Marks LB. Improving normal tissue complication probability models: the need to adopt a "data-pooling" culture. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S151-4. doi: 10.1016/j.ijrobp.2009.06.094.
- Formenti SC, DeWyngaert JK, Jozsef G, Goldberg JD. Prone vs supine positioning for breast cancer radiotherapy. JAMA. 2012 Sep 5;308(9):861-3. doi: 10.1001/2012.jama.10759.
- Moon SH, Shin KH, Kim TH, Yoon M, Park S, Lee DH, Kim JW, Kim DW, Park SY, Cho KH. Dosimetric comparison of four different external beam partial breast irradiation techniques: three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, helical tomotherapy, and proton beam therapy. Radiother Oncol. 2009 Jan;90(1):66-73. doi: 10.1016/j.radonc.2008.09.027. Epub 2008 Nov 5.
- Poortmans PM, Collette S, Kirkove C, Van Limbergen E, Budach V, Struikmans H, Collette L, Fourquet A, Maingon P, Valli M, De Winter K, Marnitz S, Barillot I, Scandolaro L, Vonk E, Rodenhuis C, Marsiglia H, Weidner N, van Tienhoven G, Glanzmann C, Kuten A, Arriagada R, Bartelink H, Van den Bogaert W; EORTC Radiation Oncology and Breast Cancer Groups. Internal Mammary and Medial Supraclavicular Irradiation in Breast Cancer. N Engl J Med. 2015 Jul 23;373(4):317-27. doi: 10.1056/NEJMoa1415369.
- Whelan TJ, Olivotto IA, Parulekar WR, Ackerman I, Chua BH, Nabid A, Vallis KA, White JR, Rousseau P, Fortin A, Pierce LJ, Manchul L, Chafe S, Nolan MC, Craighead P, Bowen J, McCready DR, Pritchard KI, Gelmon K, Murray Y, Chapman JA, Chen BE, Levine MN; MA.20 Study Investigators. Regional Nodal Irradiation in Early-Stage Breast Cancer. N Engl J Med. 2015 Jul 23;373(4):307-16. doi: 10.1056/NEJMoa1415340.
- N201603037