Breast CancerNCT06663228
Rapid Histologic Assessment for Stereotactic Breast Biopsy: Enhancing Early Detection With Miniature Mass Spectrometry and AI
An observational study of Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Breast cancer is the leading cancer among Taiwanese women, and it is the second leading cause of cancer-related deaths in women. The five-year survival rate for early-stage breast cancer (Stage 0 to II) is over 90%, significantly better than the survival rates for Stage III and Stage IV breast cancer, which are… Read more about this study
- Who is it for?
- Ages 20 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MMS
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jul 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females with abnormal mammography findings, that were categoried as ACR BI-RADS 4 or 5, come for vacuum-assisted stereotactic breast biopsy.
Who may be able to join
- Those who come for receiving vacuum-assisted stereotactic breast biopsy
Who cannot join
- Those who cannot or are unwilling to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Jo-Yu Chen
Taipei, 100
Jo-Yu Chen, MD, +886223123456 ext. 262570, juoyu.chen@gmail.com
About this study
Breast cancer is the leading cancer among Taiwanese women, and it is the second leading cause of cancer-related deaths in women. The five-year survival rate for early-stage breast cancer (Stage 0 to II) is over 90%, significantly better than the survival rates for Stage III and Stage IV breast cancer, which are approximately 70% and 25%, respectively. As a result, breast cancer screening and early diagnosis have always been of great importance. Breast cancer screening relies on imaging examinations, and the diagnosis depends on imaging-guided tissue confirmation.
However, when a patient undergoes stereotactic breast biopsy due to suspicious lesions found in mammography, they typically have to wait about a week to receive the pathology results to determine whether the lesion is benign or malignant. For the patient, this waiting period can be agonizing, and for clinicians, earlier knowledge of pathology results would facilitate prompt staging evaluation and treatment planning for cancer.
The investigators use a special technique-paper spray ionization miniature mass spectrometry (PSI-MMS). According to preliminary research, with the assistance of AI, the miniature mass spectrometer can detect the benign or malignant nature of breast tissue within minutes and with decent accuracy. The investigators hope to continue research to further improve accuracy to meet clinical needs and aspire to have the opportunity to apply the miniature mass spectrometer to rapidly differentiate the molecular subtypes of breast cancer.
- Conditions
- Breast Cancer
- Being tested
- MMS
- Keywords
- breast cancer, breast biopsy, miniature mass spectrometry, artificial intelligence
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMSDiagnostic test
miniature mass spectrometry with AI assistance
| Study group | Role | What they receive |
|---|---|---|
| breast MMS | Not described Receives: Diagnostic Test: MMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast cancer
PATHOLOGICAL DIAGNOSIS To prove the biopsy specimen to be malignant or benign.
Measured: July 2024 to July 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start17 Jul 2024
- Primary completion4 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663228
- Sponsor's protocol ID
- 202405152RINB
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Histologic Assessment for Stereotactic Breast Biopsy: Enhancing Early Detection With Miniature Mass Spectrometry and AI
- ClinicalTrials.gov ID
- NCT06663228
- Acronym / sponsor ID
- 202405152RINB
- Conditions
- Breast Cancer
- Keywords
- breast cancer, breast biopsy, miniature mass spectrometry, artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 4 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is the leading cancer among Taiwanese women, and it is the second leading cause of cancer-related deaths in women. The five-year survival rate for early-stage breast cancer (Stage 0 to II) is over 90%, significantly better than the survival rates for Stage III and Stage IV breast cancer, which are approximately 70% and 25%, respectively. As a result, breast cancer screening and early diagnosis have always been of great importance. Breast cancer screening relies on imaging examinations, and the diagnosis depends on imaging-guided tissue confirmation.
However, when a patient undergoes stereotactic breast biopsy due to suspicious lesions found in mammography, they typically have to wait about a week to receive the pathology results to determine whether the lesion is benign or malignant. For the patient, this waiting period can be agonizing, and for clinicians, earlier knowledge of pathology results would facilitate prompt staging evaluation and treatment planning for cancer.
The investigators use a special technique-paper spray ionization miniature mass spectrometry (PSI-MMS). According to preliminary research, with the assistance of AI, the miniature mass spectrometer can detect the benign or malignant nature of breast tissue within minutes and with decent accuracy. The investigators hope to continue research to further improve accuracy to meet clinical needs and aspire to have the opportunity to apply the miniature mass spectrometer to rapidly differentiate the molecular subtypes of breast cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast MMS | – | Diagnostic Test: MMS |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females with abnormal mammography findings, that were categoried as ACR BI-RADS 4 or 5, come for vacuum-assisted stereotactic breast biopsy.
Key inclusion criteria (1 listed)
- Those who come for receiving vacuum-assisted stereotactic breast biopsy
Key exclusion criteria (1 listed)
- Those who cannot or are unwilling to sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMSminiature mass spectrometry with AI assistance | Diagnostic test | breast MMS |
Primary outcome
breast cancer
Time frame: July 2024 to July 2025
PATHOLOGICAL DIAGNOSIS To prove the biopsy specimen to be malignant or benign.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jo-Yu Chen, MD (+886223123456 ext. 262570, joyuchen@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breast cancer (time frame: July 2024 to July 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.