Evaluation of the Feasibility of Developing Personalized Breast Cancer Radiotherapy Assistive Device With 3D Printing

NCT04929197 | Unknown

• 1 other identifier: N201603037
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Breast Cancer; Left Sided Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Irradiated cardiac dose

  Radiation dose distribution of the cardiopulmonary on the affected side.

  Time Frame: At simulation, expected average of 1 week

Secondary Outcomes (4)

• Irradiated dose of left anterior descending artery

  Time Frame: At simulation, expected average of 1 week

• Irradiated lung dose

  At simulation, expected average of 1 week

• Clinical target volume

  At simulation, expected average of 1 week

• Irradiated dose of axillary lymphatic area

  At simulation, expected average of 1 week

Study Arms (1)

Wear Personalized breast holder system (PERSBRA) to receiving radiotherapy

EXPERIMENTAL

Wear PERSBRA to the end of radiotherapy.

Device: PERSBRA

Interventions

PERSBRA DEVICE

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.

Wear Personalized breast holder system (PERSBRA) to receiving radiotherapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan

Location

Related Publications (6)

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  PMID: 26200977 BACKGROUND

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  PMID: 26200978 BACKGROUND

• 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.

  PMID: 20171511 BACKGROUND

• 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.

  PMID: 22948692 BACKGROUND

• 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.

  PMID: 24423396 BACKGROUND

• 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.

  PMID: 18992950 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Unilateral Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Long-Sheng Lu, MD, Ph.D.

  Taipei Medical University Hospital

  STUDY DIRECTOR

• Jeng-Feng Chiou, MD, Ph.D.

  Taipei Medical University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 18, 2021
• Study Start: April 21, 2016
• Primary Completion: April 20, 2017
• Study Completion: November 1, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)