Breast NeoplasmsDOTNCT01394315
Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer
An observational study of Breast Neoplasms, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
The aim of the study is to determine if DOT can detect response early in breast cancer patients undergoing neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 8 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2011to May 2013
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 60 patients are prescribed neaodjuvant chemotherapy for breast cancer at National Cancer Centre Singapore annually. Accrual is expected to be 10 patients per year. Up to 10 patients will be recruited for this study.
Who may be able to join
- Patients receiving neoadjuvant chemotherapy for breast cancer.
- Patients with locally advanced breast tumours or large operable tumours who require neoadjuvant treatment for downstaging.
- Histological confirmation of invasive breast carcinoma.
- Patients with metastatic disease may be eligible if they have oligometastatic disease and breast surgery after neoadjuvant chemotherapy is planned.
- Signed informed consent
- Age equal to or more than 21 years
- Life expectancy greater than 12 weeks.
- ECOG performance status 0-2
Who cannot join
- Fungating or ulcerated tumours
- Inability to provide informed consent
- Anticipated inability to follow-up patient for response to chemotherapy
- Any contraindication to undergoing ultrasound, MRI, MMG or DOT
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National Cancer Centre Singapore
Singapore, Singapore, 169610
About this study
The aim of the study is to determine if DOT can detect response early in breast cancer patients undergoing neoadjuvant chemotherapy.
Read the detailed description
The pilot study will enrol up to ten patients over one year. Patients receiving neoadjuvant chemotherapy for breast cancer will undergo baseline clinical examination, mammography, ultrasound, MRI and DOT before commencement of treatment. DOT will be repeated at 1,3,6 weeks after chemotherapy, and at the end of each chemotherapy regimen. Ultrasound will be repeated every 6 weeks and at the end of treatment. Mammography and MRI will be repeated once at the end of treatment before surgery. A breast pathologist will evaluate the subtype of breast cancer and the pathologic response of the operative specimen at the end of treatment. Patient satisfaction questionnaires will be administered to evaluate their preferences for DOT, ultrasound, mammography and MRI scanning at the beginning and the end of the study.
- Conditions
- Breast Neoplasms
- Keywords
- diffuse optical tomography, response, neoadjuvant chemotherapy, breast cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters derived from the optical images acquired with the DOT system
The primary parameters derived from the optical images acquired with the DOT system include: The volume of tumor microvasculature V, the total haemoglobin concentration (THC), and the blood volume index BVI (=VC).
Other available optical parameters are: blood oxygenation in the tumor microvasculature (SO2), its spatial distribution and dynamic fluctuation; dynamic blood perfusion.
These parameters will be compared with histopathological response.
Measured: These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
Secondary outcomes (1)
Change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation
The change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation will be correlated with response based on clinical examination, ultrasound, MMG and MRI.
Standard definitions for clinical response will be used to classify patients into four categories: complete response (CR), partial response (PR), progressive disease (PD) and stable disease (SD).
Measured: These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Principal investigator, Yap Yoon Sim, National Cancer Centre, Singapore
- Investigators
- Yoon Sim Yap, MBBS, FRACP, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394315
- Sponsor's protocol ID
- 11-7-BRE
- Acronym
- DOT
- Status last verified
- May 2013
- First submitted
- 12 Jul 2011
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT01394315
- Acronym / sponsor ID
- DOT / 11-7-BRE
- Conditions
- Breast Neoplasms
- Keywords
- diffuse optical tomography, response, neoadjuvant chemotherapy, breast cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- Aug 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Jul 2011 (estimated)
- 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.
The aim of the study is to determine if DOT can detect response early in breast cancer patients undergoing neoadjuvant chemotherapy.
Detailed description
The pilot study will enrol up to ten patients over one year. Patients receiving neoadjuvant chemotherapy for breast cancer will undergo baseline clinical examination, mammography, ultrasound, MRI and DOT before commencement of treatment. DOT will be repeated at 1,3,6 weeks after chemotherapy, and at the end of each chemotherapy regimen. Ultrasound will be repeated every 6 weeks and at the end of treatment. Mammography and MRI will be repeated once at the end of treatment before surgery. A breast pathologist will evaluate the subtype of breast cancer and the pathologic response of the operative specimen at the end of treatment. Patient satisfaction questionnaires will be administered to evaluate their preferences for DOT, ultrasound, mammography and MRI scanning at the beginning and the end of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 60 patients are prescribed neaodjuvant chemotherapy for breast cancer at National Cancer Centre Singapore annually. Accrual is expected to be 10 patients per year. Up to 10 patients will be recruited for this study.
Key inclusion criteria (8 listed)
- Patients receiving neoadjuvant chemotherapy for breast cancer.
- Patients with locally advanced breast tumours or large operable tumours who require neoadjuvant treatment for downstaging.
- Histological confirmation of invasive breast carcinoma.
- Patients with metastatic disease may be eligible if they have oligometastatic disease and breast surgery after neoadjuvant chemotherapy is planned.
- Signed informed consent
Key exclusion criteria (4 listed)
- Fungating or ulcerated tumours
- Inability to provide informed consent
- Anticipated inability to follow-up patient for response to chemotherapy
- Any contraindication to undergoing ultrasound, MRI, MMG or DOT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parameters derived from the optical images acquired with the DOT system
Time frame: These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
The primary parameters derived from the optical images acquired with the DOT system include: The volume of tumor microvasculature V, the total haemoglobin concentration (THC), and the blood volume index BVI (=VC). Other available optical parameters are: blood oxygenation in the tumor microvasculature (SO2), its spatial distribution and dynamic fluctuation; dynamic blood perfusion. These parameters will be compared with histopathological response.
1 secondary outcome
Change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation
Time frame: These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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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.
Yoon Sim Yap, MBBS, FRACP principal investigator
National Cancer Centre, Singapore
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 Neoplasms, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 May 2013. 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 Singapore. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parameters derived from the optical images acquired with the DOT system (time frame: These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months). 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 3 May 2013.