Clinical trial NCT04929197: Evaluation of the Feasibility of Developing Personalized Breast Cancer Radiotherapy Assistive Device With 3D Printing
Official title: Evaluation of the Feasibility of Developing Personalized Breast Cancer Radiotherapy Assistive Device With Three-dimensional Printing Secondary IDs:
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Breast Cancer
Left Sided Breast Cancer
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 1. Patients with early breast cancer or ductal carcinoma in situ treated with breast conservation surgery.
2. Adjuvant radiotherapy to the breast is part of the patient's initial treatment plan.
3. Non-contrast CT scan is a routine procedure for the patient's radiotherapy treatment planning.

Eligibility 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:

* Clinical diagnosis or pathological diagnosis has lymph node metastasis, lymph node micrometastasis, or lymph node tumor cells.
* The clinical diagnosis is likely to have metastatic cancer.
* Pregnant women.
* Be younger than 20 years old.
* The subject was unable to read and understand the subject consent form written in Chinese and complete the informed consent procedure.

Primary outcomes:
measure: Irradiated cardiac dose
timeFrame: Time Frame: At simulation, expected average of 1 week
Secondary outcomes:
measure: Irradiated dose of left anterior descending artery
timeFrame: Time Frame: At simulation, expected average of 1 week
measure: Irradiated lung dose
timeFrame: At simulation, expected average of 1 week
measure: Clinical target volume
timeFrame: At simulation, expected average of 1 week
measure: Irradiated dose of axillary lymphatic area
timeFrame: At simulation, expected average of 1 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Long-Sheng Lu, MD, Ph.D.
role: STUDY_DIRECTOR
affiliation: Taipei Medical University Hospital
name: Jeng-Feng Chiou, MD, Ph.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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. No abstract available.
citation: Bruzzaniti V, Abate A, Pinnaro P, D'Andrea M, Infusino E, Landoni V, Soriani A, Giordano C, Ferraro A, Strigari L. Dosimetric and clinical advantages of deep inspiration breath-hold (DIBH) during radiotherapy of breast cancer. J Exp Clin Cancer Res. 2013 Nov 7;32(1):88. doi: 10.1186/1756-9966-32-88.
citation: 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.