Infrared Spectroscopy to Analyze Volatile Organic Compounds in the Breath of Patients With Breast Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 24-013363
- Jacksonville, Florida: 24-013363
- Scottsdale/Phoenix, Arizona: 24-013363
NCT ID: NCT06512350
Sponsor Protocol Number: BBMCP2024
About this study
The purpose of this study is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical’s cavity ring-down spectrometer, the goal is to further develop Breathe BioMedical’s technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women with dense breast tissue.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Female (sex as assigned at birth).
- Aged 40 – 74 years.
- Mammography confirmed dense breast tissue (BI-RADS density score of C or D).
- Scheduled for standard of care biopsy or MRI.
- Fluent in language of consent (English, Spanish, or French).
- Ability to give informed consent.
- Able to provide a breath sample.
Exclusion Criteria:
- Mammography confirmed fatty breast tissue (BI-RADS A or B).
- Prior history of breast cancer.
- Previous surgical biopsy or surgical excision of breast cancer in the past six months.
- History of cancer (except basal cell or squamous cell carcinoma of the skin) in the past year.
- Acute respiratory infection and/or symptoms in the past seven days.
- MRI BI-RADS 3 undergoing active surveillance (MRI requiring six-month follow-up).
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 6/25/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Sandhya Pruthi, M.D. |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Jacksonville, Fla.
Mayo Clinic principal investigator James Jakub, M.D. |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Lida Mina, M.D. |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available