Breast NeoplasmsNIRNCT00499980
Near Infrared/ Ultrasound Dual Modal Imaging for Breast Cancer Diagnosis
An observational study of Breast Neoplasms, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a dynamic near infrared imaging device for characterizing suspicious breast lesions Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Aug 2005
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Non-pregnant (as defined by previous tubal ligation, no menses for last 12 consecutive months, or a negative quantitative serum pregnancy test on the day of the procedure.)
- Age: 18 years or older
- Suspicious lesion (BIRAD 4 or 5) identified by mammography and/or by ultrasound.
- A breast biopsy has been scheduled
- The suspicious lesion size is between 0.5 cm and 2 cm.
- The suspicious lesion depth is less than 3 cm from skin surface.
- The suspicious lesion should be clearly evident by ultrasound imaging
Who cannot join
- Patient with the biopsy performed to the suspicious lesion in the past 2 months on the same breast will be excluded from the study
- Patient with tattoos overlying the area of the suspicious lesion will be excluded from the study
- Patients with prior breast radiation therapy will be excluded from the study
- Patients with prior breast reduction surgery or breast augmentation surgery to the same breast will be excluded from the study
- Patients with previous surgical biopsy at or near the site of the suspicious lesion will be excluded from the study
- Patients with prior history of breast cancer in the same breast will be excluded from the study
- Patient who does not sign the consent form will be excluded from the study
- Patients that have not completed all studies of mammography and/or clinical ultrasound, P-Scan, Terason ultrasound and biopsy will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Pilot Clinical Trial Evaluating the Utility of a Dynamic Near Infrared Imaging Device for Characterizing Suspicious Breast Lesions
The purpose of this study is to evaluate a dynamic near infrared imaging device for characterizing suspicious breast lesions
Read the detailed description
Breast cancer is the leading cause of cancer among women in the United States. It has always been the hope that devising methods of earlier detection would lead to improvement of long-term survival. Therefore, the development of novel, more selective, and noninvasive diagnostic techniques is a priority. Mammography is currently the most commonly used breast imaging modality for both screening and diagnostic purposes. Additionally, breast ultrasound imaging and breast magnetic resonance imaging (MRI) are generally used to supplement or help confirm any indeterminate or suspicious finding prior to consideration of a breast biopsy. However, these conventional imaging methods lack information about tissue function and have lower diagnostic accuracy.
Most recently, near infrared (NIR, of wavelength 700-900 nm) optical diffuse spectroscopic imaging has been investigated as a novel diagnostic tool for breast cancer. In the near-infrared (NIR) light spectrum, oxygenated hemoglobin and deoxygenated hemoglobin are the major chromospheres in tissue, and the absorption spectrums of the two hemoglobin states differ across these wavelengths. Thus, there have been many contemporary attempts to use the intra-tissue absorption and scattering of NIR light to quantify functional tissue parameters such as hemoglobin concentration (HbT) and oxygen saturation (StO2), including tumor differentiation within the human breast. To a very good approximation, NIR photons diffuse through relatively thick tissues, such as several centimeters of a human breast. Functional imaging with NIR light offers several novel tissue parameters that differentiate tumors from normal breast tissue. For example, hemoglobin de-saturation in tumors may be increased due to the high oxygen demand of cancers and blood volume may be increased over that of normal background tissue due to the greater vascularization and metabolic needs of cancers.
While NIR imaging provides additional physiological parameters that potentially help to improve the specificity of breast cancer diagnosis, its relatively low spatial resolution makes it unsuitable for morphological analysis. The resolution of a NIR system is intrinsically limited by the diffusive nature of the near infrared light in tissue. Currently, typical instruments can distinguish simple structures of approximately 1 cm in size; sharp edges are typically blurred by a few millimeters. It was proposed that the imaging technique combining near infrared and ultrasound modalities has the potential to fully utilize their complementary features and overcome their deficiencies. This protocol defines the clinical study to prove the concept of the near infrared/ ultrasound dual modal imaging and to evaluate its sensitivity and specificity for breast cancer diagnosis.
- Conditions
- Breast Neoplasms
- Keywords
- Breast cancer, Spectroscopy, Near-Infrared, Oximetry
- 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 posted12 Jul 2007 (estimated)
- Study startMar 2005
- Study completionAug 2005
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.
- More trials run by Ohio State UniversityThe 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
- Defined population
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- ViOptix Canada
- Investigators
- Ronald X Xu, PhD, Principal investigator, Department of Biomedical Engineering, OSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499980
- Sponsor's protocol ID
- OSU-04117
- Acronym
- NIR
- Status last verified
- Jul 2007
- First submitted
- 11 Jul 2007
- Last updated
- 12 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Clinical Trial Evaluating the Utility of a Dynamic Near Infrared Imaging Device for Characterizing Suspicious Breast Lesions
- ClinicalTrials.gov ID
- NCT00499980
- Acronym / sponsor ID
- NIR / OSU-04117
- Conditions
- Breast Neoplasms
- Keywords
- Breast cancer, Spectroscopy, Near-Infrared, Oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- ViOptix Canada
- Study start
- Mar 2005
- Study completion
- Aug 2005 (actual)
- First posted
- 12 Jul 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.
The purpose of this study is to evaluate a dynamic near infrared imaging device for characterizing suspicious breast lesions
Detailed description
Breast cancer is the leading cause of cancer among women in the United States. It has always been the hope that devising methods of earlier detection would lead to improvement of long-term survival. Therefore, the development of novel, more selective, and noninvasive diagnostic techniques is a priority. Mammography is currently the most commonly used breast imaging modality for both screening and diagnostic purposes. Additionally, breast ultrasound imaging and breast magnetic resonance imaging (MRI) are generally used to supplement or help confirm any indeterminate or suspicious finding prior to consideration of a breast biopsy. However, these conventional imaging methods lack information about tissue function and have lower diagnostic accuracy.
Most recently, near infrared (NIR, of wavelength 700-900 nm) optical diffuse spectroscopic imaging has been investigated as a novel diagnostic tool for breast cancer. In the near-infrared (NIR) light spectrum, oxygenated hemoglobin and deoxygenated hemoglobin are the major chromospheres in tissue, and the absorption spectrums of the two hemoglobin states differ across these wavelengths. Thus, there have been many contemporary attempts to use the intra-tissue absorption and scattering of NIR light to quantify functional tissue parameters such as hemoglobin concentration (HbT) and oxygen saturation (StO2), including tumor differentiation within the human breast. To a very good approximation, NIR photons diffuse through relatively thick tissues, such as several centimeters of a human breast. Functional imaging with NIR light offers several novel tissue parameters that differentiate tumors from normal breast tissue. For example, hemoglobin de-saturation in tumors may be increased due to the high oxygen demand of cancers and blood volume may be increased over that of normal background tissue due to the greater vascularization and metabolic needs of cancers.
While NIR imaging provides additional physiological parameters that potentially help to improve the specificity of breast cancer diagnosis, its relatively low spatial resolution makes it unsuitable for morphological analysis. The resolution of a NIR system is intrinsically limited by the diffusive nature of the near infrared light in tissue. Currently, typical instruments can distinguish simple structures of approximately 1 cm in size; sharp edges are typically blurred by a few millimeters. It was proposed that the imaging technique combining near infrared and ultrasound modalities has the potential to fully utilize their complementary features and overcome their deficiencies. This protocol defines the clinical study to prove the concept of the near infrared/ ultrasound dual modal imaging and to evaluate its sensitivity and specificity for breast cancer diagnosis.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female
- Non-pregnant (as defined by previous tubal ligation, no menses for last 12 consecutive months, or a negative quantitative serum pregnancy test on the day of the procedure.)
- Age: 18 years or older
- Suspicious lesion (BIRAD 4 or 5) identified by mammography and/or by ultrasound.
- A breast biopsy has been scheduled
Key exclusion criteria (8 listed)
- Patient with the biopsy performed to the suspicious lesion in the past 2 months on the same breast will be excluded from the study
- Patient with tattoos overlying the area of the suspicious lesion will be excluded from the study
- Patients with prior breast radiation therapy will be excluded from the study
- Patients with prior breast reduction surgery or breast augmentation surgery to the same breast will be excluded from the study
- Patients with previous surgical biopsy at or near the site of the suspicious lesion will be excluded from the study
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2007.
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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.
Ronald X Xu, PhD principal investigator
Department of Biomedical Engineering, OSU
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 Ohio State University at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 12 Jul 2007. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 12 Jul 2007.