Breast Neoplasm FemaleNCT03271853
Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.
An observational study of Breast Neoplasm Female and Cancer, Breast, run by First Sense Medical, LLC at 1 site in United States.
Trial summary
This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasm Female, Cancer, Breast, Thermography
- What is being tested?
- Sentinel BreastScan II
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2017to 1 Sep 2026
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population consists of any patient undergoing standard mammographic examination and/or any additional imaging study predicated on the results of mammography.
Who may be able to join
- Male or Female, over the age of 18 years of age.
- Asymptomatic women or women who are being screened for breast abnormality.
- Women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and FS/TS system.
- Not pregnant or breast feeding.
- Signed Informed consent.
Who cannot join
- Subject does not meet inclusion criteria, noted above.
- Use of 100 mg or more of niacin by tablet or niacin patch within the last 24 hours.
- Use of nitroglycerin within the last 24 hours.
- Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study.
- Subject must not have had a mammogram, breast ultrasound, or breast exam within the last 72 hours prior to the SBS II.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eleanor N. Dana Cancer Center, University of Toledo
Toledo, Ohio, 43614
About this study
This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan.
Read the detailed description
FirstSense Medical, LLC is a medical device company which has developed a breast cancer screening device, the Sentinel BreastScan II [SBS II]. This radiation free device is being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. Dr. Hoekstra, CEO of Therma-Scan, is the author of a published paper based on breast thermal data with a reported 95% sensitivity and 91% specificity. The SBS II examination will take approximately 7 minutes.
This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan. SBS II thermal breast data is an adjunctive aid to standard breast imaging. Currently, mammography is one of the standards of care in screening for visible signs of breast cancer. Breast thermology is the analysis of the heat signature data from an examined breast. All study costs will be incurred by the sponsor. Study subjects will incur no cost to participate. All scientific data revealed in this protocol will be used for the specific objectives of the study. The SBS II is a non-significant risk device. There is no contact with the subject during the entire procedure.
- Conditions
- Breast Neoplasm Female, Cancer, Breast, Thermography
- Being tested
- Sentinel BreastScan II
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel BreastScan IIDevice
The SBS II will automate the recording of thermal data used in the Therma-Scan manual thermology protocol by utilizing a thermal camera sensitive to changes in breast temperature. The SBS II system uses a very sensitive thermography camera that detects and visually displays heat patterns that naturally emanate from the breast. SBS II captures this data digitally for subsequent analysis by Therma-Scan.
| Study group | Role | What they receive |
|---|---|---|
| SBS II | Not described Receives: Device: Sentinel BreastScan II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure protocol accuracy
To measure the sensitivity and specificity of thermographic analysis based on the Marseilles analytic protocol [ Th 1 thru 5 ] to biopsy results predicated on standard breast imaging criteria [ BIRADS analytical protocol, B1 thru B5 ]. The resultant BIRADS score and biopsy pathological results will be compared to thermographic analysis [ Th1 thru 5 ] for each subject. 50 subjects undergoing both thermography and standard breast imaging leading to biopsy [ BIRADS 3 thru 5 ] will then be compared by measuring the results of each, BIRADS for standard breast imaging v the Marseilles Th system used in thermographic analysis, for concordance or discordance of findings as measured on final pathological analysis. This analysis will be performed for each subsequent 50 patient cohort undergoing standard mammographic/ultrasound breast imaging analysis.
Measured: Through study completion, an average of 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start3 Nov 2017
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2026 (estimated)
Why it stopped: Trial temporarily halted to conduct additional device testing to verify cooling data. This temporary halt is NOT due to a potential risk to subject safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Sense Medical, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toledo Health Science Campus
- Responsible party
- Sponsor
- Investigators
- Haitham Elsamaloty, Principal investigator, University of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271853
- Sponsor's protocol ID
- SBS-001
- Status last verified
- Jan 2018
- First submitted
- 24 Jul 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.
- ClinicalTrials.gov ID
- NCT03271853
- Acronym / sponsor ID
- SBS-001
- Conditions
- Breast Neoplasm Female, Cancer, Breast, Thermography
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Trial temporarily halted to conduct additional device testing to verify cooling data. This temporary halt is NOT due to a potential risk to subject safety.
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- First Sense Medical, LLCUniversity, hospital or other
- Collaborators
- University of Toledo Health Science Campus
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Sep 2017 (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.
This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan.
Detailed description
FirstSense Medical, LLC is a medical device company which has developed a breast cancer screening device, the Sentinel BreastScan II [SBS II]. This radiation free device is being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. Dr. Hoekstra, CEO of Therma-Scan, is the author of a published paper based on breast thermal data with a reported 95% sensitivity and 91% specificity. The SBS II examination will take approximately 7 minutes.
This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan. SBS II thermal breast data is an adjunctive aid to standard breast imaging. Currently, mammography is one of the standards of care in screening for visible signs of breast cancer. Breast thermology is the analysis of the heat signature data from an examined breast. All study costs will be incurred by the sponsor. Study subjects will incur no cost to participate. All scientific data revealed in this protocol will be used for the specific objectives of the study. The SBS II is a non-significant risk device. There is no contact with the subject during the entire procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBS II | – | Device: Sentinel BreastScan II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consists of any patient undergoing standard mammographic examination and/or any additional imaging study predicated on the results of mammography.
Key inclusion criteria (5 listed)
- Male or Female, over the age of 18 years of age.
- Asymptomatic women or women who are being screened for breast abnormality.
- Women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and FS/TS system.
- Not pregnant or breast feeding.
- Signed Informed consent.
Key exclusion criteria (5 listed)
- Subject does not meet inclusion criteria, noted above.
- Use of 100 mg or more of niacin by tablet or niacin patch within the last 24 hours.
- Use of nitroglycerin within the last 24 hours.
- Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study.
- Subject must not have had a mammogram, breast ultrasound, or breast exam within the last 72 hours prior to the SBS II.
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 |
|---|---|---|
| Sentinel BreastScan IIThe SBS II will automate the recording of thermal data used in the Therma-Scan manual thermology protocol by utilizing a thermal camera sensitive to changes in breast temperature. The SBS II system uses a very sensitive thermography camera that detects and visually displays heat patterns that naturally emanate from the breast. SBS II captures this data digitally for subsequent analysis by Therma-Scan. | Device | SBS II |
Primary outcome
Measure protocol accuracy
Time frame: Through study completion, an average of 4 years.
To measure the sensitivity and specificity of thermographic analysis based on the Marseilles analytic protocol [ Th 1 thru 5 ] to biopsy results predicated on standard breast imaging criteria [ BIRADS analytical protocol, B1 thru B5 ]. The resultant BIRADS score and biopsy pathological results will be compared to thermographic analysis [ Th1 thru 5 ] for each subject. 50 subjects undergoing both thermography and standard breast imaging leading to biopsy [ BIRADS 3 thru 5 ] will then be compared by measuring the results of each, BIRADS for standard breast imaging v the Marseilles Th system used in thermographic analysis, for concordance or discordance of findings as measured on final pathological analysis. This analysis will be performed for each subsequent 50 patient cohort undergoing standard mammographic/ultrasound breast imaging analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
Related trials for Breast Neoplasm Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
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.
Haitham Elsamaloty principal investigator
University of Toledo
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 Neoplasm Female and Cancer, Breast, run by First Sense Medical, LLC 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 5 inclusion and 5 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: paused, as of the sponsor's last update on 10 Jan 2018. 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?
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?
Measure protocol accuracy (time frame: Through study completion, an average of 4 years.). 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 10 Jan 2018.