Breast CancerNCT00438074
A Pilot Study To Evaluate the Effectiveness of Pulsed Time-Domain Optical Spectroscopy for Monitoring the Responses in Neoadjuvant Treatments of Locally-Advanced Breast Cancer
An observational study of Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This study will investigate optical tissue characteristics as a function of neoadjuvant breast cancer treatment. Our objective in this pilot study will be to identify diffuse optical spectroscopy parameters that change with treatment and that may correlate with pathological response. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2007to 17 May 2024
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who are receiving neoadjuvant chemotherapy or neoadjuvant chemo-radiotherapy for locally-advanced breast cancer.
Who may be able to join
- Locally Advance Breast Cancer
- Subjects must give appropriate written informed consent prior to participation in the study;
- Subjects must be able and willing to comply with the safety procedures during the Scanning Period;
- Subjects must be women of between 20 and 80 years of age, inclusive, on the day the Informed Consent Form is signed;
- Subjects must be women who will be receiving neoadjuvant radiation therapy and/or chemotherapy for locally-advanced breast cancer.
- Subjects of childbearing potential must be using an acceptable method of birth control. Subjects not of childbearing potential are defined as either surgically sterile or post-menopausal. Post-menopausal women are defined as those women with a documented menstruation cessation for 12 consecutive months prior to signing the Informed Consent Form
Who cannot join
- Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g.,silicone/saline implants) involving either breast, exclusive of the lesion at issue;
- Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast;
- Subjects with a current or past medical history of connective tissue disease;
- Subjects who are pregnant or lactating;
- Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator;
- Subjects with a history or expectation of significant anxiety associated with undergoing diagnostic evaluations;
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- Subjects with a history of musculoskeletal disease which may predispose them to discomfort during the Scanning Period;
- Subjects with a known sensitivity to purified water, soybean oil, sucrose, polysorbate 80, oleic acid, EDTA, benzalkonium chloride, FD\&C caramel color, butylated hydroxyanisole, and/or sodium hydroxide;
- Subjects with a known sensitivity to low-power infrared radiation (e.g., as a result of a dermatologic condition); and
- Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Gregory J. Czarnota, Ph.D. M.D.
About this study
This study will investigate optical tissue characteristics as a function of neoadjuvant breast cancer treatment. Our objective in this pilot study will be to identify diffuse optical spectroscopy parameters that change with treatment and that may correlate with pathological response. The ultimate goal is to use such parameters ultrasound as an early predictor of pathological partial or complete response in women with locally advanced breast cancer receiving treatment with neoadjuvant treatments such as chemotherapy or neoadjuvant combined modality chemotherapy and radiotherapy.
Read the detailed description
Breast cancer is the most common malignancy for females in North America. Around 5-15% of the estimated 200,000 new cases diagnosed each year will present with locally advanced breast cancer (LABC) (The definition of what constitutes "LABC" is complex and variable. Clinically these tumours are usually considered to be those greater than 5cm in size and/or extend beyond the breast tissue into the surrounding skin or muscle. Patients with matted axillary lymph nodes (N2) or internal mammary nodes (N3) or ipsilateral supraclavicular lymph node involvement are also considered to have LABC. In view of the extensive nature of these tumours at presentation, women with LABC have a poor outcome in terms of both local and systemic recurrence. Standard treatment for these patients is usually neoadjuvant systemic (chemotherapy or less frequently endocrine therapy) followed by surgery and radiotherapy. Patients who have hormone receptor positive tumours will then receive endocrine therapy. With the use of multidisciplinary therapy, 10-year disease free survival rates of 50% for Stage IIIA and 33% for Stage IIIB disease have been reported.
The impetus for undertaking this study is that we are searching for imaging methods that could potentially serve as surrogate indicators of pathological response. One such modality that we wish to investigate as it may be ultimately useful in this patient population is diffuse optical spectrometry. This modality depends on differentiating oxygenated from deoxygenated tissue but is also sensitive to other changes in tissue characteristics. It has been used before in proof-of-principle studies differentiating benign from malignant disease but we hypothesize that it may be more useful in terms of monitoring tumour responses to treatment. This is a non-invasive imaging modality that is easy to administer and relatively inexpensive.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Diffuse Optical Spectroscopy
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completion17 May 2024 (estimated)
- Study completion17 May 2024 (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.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- ART Advanced Research Technologies Inc.
- Responsible party
- Principal investigator, Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre
- Investigators
- Gregory J. Czarnota, Ph.D. M.D., Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438074
- Sponsor's protocol ID
- 186-2006
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2007
- Last updated
- 9 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study To Evaluate the Effectiveness of Pulsed Time-Domain Optical Spectroscopy for Monitoring the Responses in Neoadjuvant Treatments of Locally-Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00438074
- Acronym / sponsor ID
- 186-2006
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Diffuse Optical Spectroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- ART Advanced Research Technologies Inc.
- Study start
- Feb 2007
- Primary completion
- 17 May 2024 (estimated)
- Study completion
- 17 May 2024 (estimated)
- First posted
- 21 Feb 2007 (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.
This study will investigate optical tissue characteristics as a function of neoadjuvant breast cancer treatment. Our objective in this pilot study will be to identify diffuse optical spectroscopy parameters that change with treatment and that may correlate with pathological response. The ultimate goal is to use such parameters ultrasound as an early predictor of pathological partial or complete response in women with locally advanced breast cancer receiving treatment with neoadjuvant treatments such as chemotherapy or neoadjuvant combined modality chemotherapy and radiotherapy.
Detailed description
Breast cancer is the most common malignancy for females in North America. Around 5-15% of the estimated 200,000 new cases diagnosed each year will present with locally advanced breast cancer (LABC) (The definition of what constitutes "LABC" is complex and variable. Clinically these tumours are usually considered to be those greater than 5cm in size and/or extend beyond the breast tissue into the surrounding skin or muscle. Patients with matted axillary lymph nodes (N2) or internal mammary nodes (N3) or ipsilateral supraclavicular lymph node involvement are also considered to have LABC. In view of the extensive nature of these tumours at presentation, women with LABC have a poor outcome in terms of both local and systemic recurrence. Standard treatment for these patients is usually neoadjuvant systemic (chemotherapy or less frequently endocrine therapy) followed by surgery and radiotherapy. Patients who have hormone receptor positive tumours will then receive endocrine therapy. With the use of multidisciplinary therapy, 10-year disease free survival rates of 50% for Stage IIIA and 33% for Stage IIIB disease have been reported.
The impetus for undertaking this study is that we are searching for imaging methods that could potentially serve as surrogate indicators of pathological response. One such modality that we wish to investigate as it may be ultimately useful in this patient population is diffuse optical spectrometry. This modality depends on differentiating oxygenated from deoxygenated tissue but is also sensitive to other changes in tissue characteristics. It has been used before in proof-of-principle studies differentiating benign from malignant disease but we hypothesize that it may be more useful in terms of monitoring tumour responses to treatment. This is a non-invasive imaging modality that is easy to administer and relatively inexpensive.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are receiving neoadjuvant chemotherapy or neoadjuvant chemo-radiotherapy for locally-advanced breast cancer.
Key inclusion criteria (6 listed)
- Locally Advance Breast Cancer
- Subjects must give appropriate written informed consent prior to participation in the study;
- Subjects must be able and willing to comply with the safety procedures during the Scanning Period;
- Subjects must be women of between 20 and 80 years of age, inclusive, on the day the Informed Consent Form is signed;
- Subjects must be women who will be receiving neoadjuvant radiation therapy and/or chemotherapy for locally-advanced breast cancer.
Key exclusion criteria (10 listed)
- Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g.,silicone/saline implants) involving either breast, exclusive of the lesion at issue;
- Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast;
- Subjects with a current or past medical history of connective tissue disease;
- Subjects who are pregnant or lactating;
- Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator;
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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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.
Gregory J. Czarnota, Ph.D. M.D. principal investigator
Sunnybrook Health Sciences Centre
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 Sunnybrook Health Sciences Centre at 1 site in Canada.
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 6 inclusion and 10 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 9 Feb 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 Canada. 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 Gregory J Czarnota (416-480-5329, gregory.czarnota@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 9 Feb 2024; AzTrials last refreshed its copy on 31 Oct 2026.