Evaluation of the Feasibility of Developing Personalized Breast Cancer Radiotherapy Assistive Device With 3D Printing (PERSBRA)
Primary Purpose
Breast Neoplasms, Breast Cancer, Left Sided Breast Cancer
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PERSBRA
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
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.
Sites / Locations
- Taipei Medical University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wear Personalized breast holder system (PERSBRA) to receiving radiotherapy
Arm Description
Wear PERSBRA to the end of radiotherapy.
Outcomes
Primary Outcome Measures
Irradiated cardiac dose
Radiation dose distribution of the cardiopulmonary on the affected side.
Secondary Outcome Measures
Irradiated dose of left anterior descending artery
Radiation dose distribution of the left anterior descending artery on the affected side.
Irradiated lung dose
Radiation dose distribution of the lung on the affected side.
Clinical target volume
Radiation dose distribution of clinical target volume.
Irradiated dose of axillary lymphatic area
Irradiated dose of axillary lymphatic area.
Full Information
NCT ID
NCT04929197
First Posted
May 31, 2021
Last Updated
November 3, 2022
Sponsor
Taipei Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04929197
Brief Title
Evaluation of the Feasibility of Developing Personalized Breast Cancer Radiotherapy Assistive Device With 3D Printing
Acronym
PERSBRA
Official Title
Evaluation of the Feasibility of Developing Personalized Breast Cancer Radiotherapy Assistive Device With Three-dimensional Printing Secondary IDs:
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 21, 2016 (Actual)
Primary Completion Date
April 20, 2017 (Actual)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
Detailed Description
Patients with early breast cancer or ductal carcinoma in situ treated with breast conservation surgery.
Adjuvant radiotherapy to the breast is part of the patient's initial treatment plan.
Non-contrast CT scan is a routine procedure for the patient's radiotherapy treatment planning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Breast Cancer, Left Sided Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wear Personalized breast holder system (PERSBRA) to receiving radiotherapy
Arm Type
Experimental
Arm Description
Wear PERSBRA to the end of radiotherapy.
Intervention Type
Device
Intervention Name(s)
PERSBRA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Irradiated cardiac dose
Description
Radiation dose distribution of the cardiopulmonary on the affected side.
Time Frame
Time Frame: At simulation, expected average of 1 week
Secondary Outcome Measure Information:
Title
Irradiated dose of left anterior descending artery
Description
Radiation dose distribution of the left anterior descending artery on the affected side.
Time Frame
Time Frame: At simulation, expected average of 1 week
Title
Irradiated lung dose
Description
Radiation dose distribution of the lung on the affected side.
Time Frame
At simulation, expected average of 1 week
Title
Clinical target volume
Description
Radiation dose distribution of clinical target volume.
Time Frame
At simulation, expected average of 1 week
Title
Irradiated dose of axillary lymphatic area
Description
Irradiated dose of axillary lymphatic area.
Time Frame
At simulation, expected average of 1 week
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Long-Sheng Lu, MD, Ph.D.
Organizational Affiliation
Taipei Medical University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeng-Feng Chiou, MD, Ph.D.
Organizational Affiliation
Taipei Medical University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Medical University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26200977
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Evaluation of the Feasibility of Developing Personalized Breast Cancer Radiotherapy Assistive Device With 3D Printing
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