Breast NeoplasmNCT01755130
Laser Optoacoustic and Ultrasonic Imaging System Assembly in Finding Changes in Tumors in Patients With Breast Cancer
A study testing Photoacoustic Imaging in people with Breast Neoplasm and Inflammatory Breast Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies laser optoacoustic and ultrasonic imaging system assembly in finding changes in tumors in patients with breast cancer. Diagnostic procedures, such as laser optoacoustic and ultrasonic imaging system assembly, may help find and diagnose breast cancer and find out how far the disease has… Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Breast Neoplasm, Inflammatory Breast Carcinoma
- What is being tested?
- Photoacoustic Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2014to 2 Jun 2021
- Phase
- Interventional
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mass palpable or nonpalpable
- Tissue density - all tissue types
- Menses - any stage of cycle
- Suspicious breast mass(es) defined by mammography or ultrasound indicating biopsy is needed (biopsy not needed if previous biopsy results are available on target lesion[s])
- Tumor location - the mammography or ultrasound report should not say that the tumor is in close proximity of chest wall
- Any tumor type (patients with inflammatory breast cancer may be included)
Who cannot join
- Patient is unable or unwilling to give informed consent for any reason
- Disability (psychiatric, neurological or physical, which precludes examination)
- Patient has tattoos on the region of interest
- Overweight over 250 pounds (LB)
- Very large breast size exceeding 6 inch diameter
- Patient has body piercing jewelry through the nipple that cannot be removed
Show all 15Show fewer
- Patient has had a core or excisional biopsy in the ipsilateral breast within the last 2 weeks (patients with previous fine needle aspirations but no ultrasound evidence of hematoma or post biopsy [bx] change may be included)
- Patient has inflammatory skin disease (i.e., psoriasis, eczema) or other irritation affecting the breast
- Patient has any pain or high sensitivity in the breast
- Currently taking hormonal replacement therapy
- Non-ambulatory or unable to comply with exam
- Pregnant (pregnancy test is not required, only as confirmed by patient)
- Breastfeeding
- Prior breast treatment for target lesion
- Previous surgery of the breast in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimode Laser Optoacoustic Ultrasonic Tomography System for Breast Cancer Care
This clinical trial studies laser optoacoustic and ultrasonic imaging system assembly in finding changes in tumors in patients with breast cancer. Diagnostic procedures, such as laser optoacoustic and ultrasonic imaging system assembly, may help find and diagnose breast cancer and find out how far the disease has spread.
Read the detailed description
PRIMARY OBJECTIVES:
- To successfully obtain images from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D) and assess pathology in order to guide image calibration and gain knowledge about LOUISA 3D capabilities to detect and differentiate breast tumors.
II. Estimate and compare the false positive rate of LOUISA-3D compared to standard of care ultrasound for detecting breast cancer in year 5 of the study.
SECONDARY OBJECTIVES:
- Determine optimal scanning parameters by assessing certain machine parameters (e.g. illumination and detection conditions, laser pulse repetition rate, laser ultrasound emission characteristics, type of imaging probe, two-dimensional images vs three-dimensional images, coupling medium characteristics, software and firmware, etc.), anatomical information (speed of sound image, acoustic attenuation image, acoustic scattering image), and functional information (total hemoglobin distribution [THb]/image of angiogenesis density, image of blood oxygen saturation [SO2], and image of water distribution).
OUTLINE:
Patients undergo LOUISA 3D over approximately 30 minutes on the same day or within 7 days of any breast imaging procedure and within 7 days before biopsy.
- Conditions
- Breast Neoplasm, Inflammatory Breast Carcinoma
- Being tested
- Photoacoustic Imaging
- Medical subject headings
- Breast Neoplasms, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoacoustic ImagingProcedure or surgery
Undergo LOUISA 3D
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (LOUISA 3D) | Experimental | Patients undergo LOUISA 3D over approximately 30 minutes on the same day or within 7 days of any breast imaging procedure and within 7 days before biopsy. Receives: Procedure: Photoacoustic Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of images successfully obtained from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D)
Pathology will provide useful information including but not limited to type of malignancy, tissue type, and other qualitative information that is necessary for image calibration.
Measured: Within 7 days of the standard of care ultrasound
False positive rate of LOUISA 3D and standard of care ultrasound
McNemar's test will be used to compare paired proportions and relative false positive rates.
Measured: Within 7 days of the standard of care ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study start13 May 2014
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Why it stopped: due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Yang, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755130
- Sponsor's protocol ID
- 2012-0210
- Other IDs
- NCI-2014-01243, NCI-2013-00149, 2012-0210
- Status last verified
- Jun 2021
- First submitted
- 18 Dec 2012
- Last updated
- 29 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimode Laser Optoacoustic Ultrasonic Tomography System for Breast Cancer Care
- ClinicalTrials.gov ID
- NCT01755130
- Acronym / sponsor ID
- 2012-0210
- Conditions
- Breast Neoplasm, Inflammatory Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to lack of funding
- Enrolment
- 9 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 13 May 2014 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 24 Dec 2012 (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 clinical trial studies laser optoacoustic and ultrasonic imaging system assembly in finding changes in tumors in patients with breast cancer. Diagnostic procedures, such as laser optoacoustic and ultrasonic imaging system assembly, may help find and diagnose breast cancer and find out how far the disease has spread.
Detailed description
PRIMARY OBJECTIVES:
- To successfully obtain images from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D) and assess pathology in order to guide image calibration and gain knowledge about LOUISA 3D capabilities to detect and differentiate breast tumors.
II. Estimate and compare the false positive rate of LOUISA-3D compared to standard of care ultrasound for detecting breast cancer in year 5 of the study.
SECONDARY OBJECTIVES:
- Determine optimal scanning parameters by assessing certain machine parameters (e.g. illumination and detection conditions, laser pulse repetition rate, laser ultrasound emission characteristics, type of imaging probe, two-dimensional images vs three-dimensional images, coupling medium characteristics, software and firmware, etc.), anatomical information (speed of sound image, acoustic attenuation image, acoustic scattering image), and functional information (total hemoglobin distribution [THb]/image of angiogenesis density, image of blood oxygen saturation [SO2], and image of water distribution).
OUTLINE:
Patients undergo LOUISA 3D over approximately 30 minutes on the same day or within 7 days of any breast imaging procedure and within 7 days before biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (LOUISA 3D) | Experimental | Procedure: Photoacoustic ImagingPatients undergo LOUISA 3D over approximately 30 minutes on the same day or within 7 days of any breast imaging procedure and within 7 days before biopsy. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mass palpable or nonpalpable
- Tissue density - all tissue types
- Menses - any stage of cycle
- Suspicious breast mass(es) defined by mammography or ultrasound indicating biopsy is needed (biopsy not needed if previous biopsy results are available on target lesion[s])
- Tumor location - the mammography or ultrasound report should not say that the tumor is in close proximity of chest wall
Key exclusion criteria (15 listed)
- Patient is unable or unwilling to give informed consent for any reason
- Disability (psychiatric, neurological or physical, which precludes examination)
- Patient has tattoos on the region of interest
- Overweight over 250 pounds (LB)
- Very large breast size exceeding 6 inch diameter
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 |
|---|---|---|
| Photoacoustic ImagingUndergo LOUISA 3D | Procedure or surgery | Diagnostic (LOUISA 3D) |
Primary outcome
Number of images successfully obtained from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D)
Time frame: Within 7 days of the standard of care ultrasound
Pathology will provide useful information including but not limited to type of malignancy, tissue type, and other qualitative information that is necessary for image calibration.
False positive rate of LOUISA 3D and standard of care ultrasound
Time frame: Within 7 days of the standard of care ultrasound
McNemar's test will be used to compare paired proportions and relative false positive rates.
Results and safety
The study was stopped early (reason given: due to lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Wei Yang principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photoacoustic Imaging in people with Breast Neoplasm and Inflammatory Breast Carcinoma, run by M.D. Anderson Cancer Center 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 6 inclusion and 15 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 29 Jun 2021. 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 was stopped early (reason given: due to lack of funding). 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?
Number of images successfully obtained from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D) (time frame: Within 7 days of the standard of care ultrasound). The study lists 2 primary outcomes in all. 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 Jun 2021.