Breast CancerNCT00783757
TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer
A study testing Optical Imaging in people with Breast Cancer, run by Steven Isakoff, MD, PhD at 1 site in United States.
Trial summary
The purpose of this research study is to see if Near-Infrared Tomographic Optical Breast Imaging (TOBI) scans can help monitor breast tumor response during treatment for breast cancer. The images created by the TOBI scan show changes in blood blow and oxygen levels in breast tissue. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Optical Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jun 2017
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patients presenting to the MGH Cancer Center Gillette Center for breast cancer neoadjuvant therapy
- Subject who have had or will have a clinically indicated pre-treatment breast MRI
Who cannot join
- Younger than 18 years of age
- Open wounds on breast
- Breast implants, because they may interfere with readings
- Subjects who will be receiving preoperative therapy for <28 days
- Breast surgery or biopsy < 10 days prior to optical imaging scan
- Medical or psychiatric or other medical condition that the principal investigator believes may result in inability to complete the study
- Bilateral breast cancers or a history of contralateral breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Functional Metabolic Near-infrared Tomographic Optical Breast Imaging (TOBI) to Monitor Response to Neoadjuvant Therapy in Breast Cancer
The purpose of this research study is to see if Near-Infrared Tomographic Optical Breast Imaging (TOBI) scans can help monitor breast tumor response during treatment for breast cancer. The images created by the TOBI scan show changes in blood blow and oxygen levels in breast tissue.
Read the detailed description
- Participants will have a TOBI scan prior to starting their cancer treatment and again on day 8 after their first treatment. Participants will also be asked if they would volunteer to undergoing one or more additional TOBI scans on days 2-7 after they begin cancer treatment. These additional scans are optional. Participants will also have a scan on the first day of each treatment cycle.
- TOBI scans will be performed at the Gillette Center for Breast Cancer at the Massachusetts General Hospital.
- For the scan, each breast is placed between 2 plastic plates in order to spread the tissue apart, similar to the procedure for a mammogram. The TOBI scanner is attached to these plates. We will apply mild pressure to compress the breast and the breast will be scanned using light waves. Each scan will take about 3 minutes.
- Conditions
- Breast Cancer
- Being tested
- Optical Imaging
- Keywords
- neo-adjuvant chemotherapy, TOBI, breast imaging, optical imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical ImagingDevice
Also called TOBI
TOBI scan performed before the participant starts cancer treatment and at the start of each treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| Optical Imaging | Experimental | Tomographic Optical Imaging Arm Receives: Device: Optical Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the feasibility of measuring optically derived parameters in the clinical setting.
Measured: 4 years
Secondary outcomes (2)
To explore the changes before and after neoadjuvant therapy of additional parameters derived from dynamic and static optical imaging of primary breast cancer.
Measured: 4 years
To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2014
- Study completionJun 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven Isakoff, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steven Isakoff, MD, PhD, Massachusetts General Hospital
- Investigators
- Steven Isakoff, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783757
- Sponsor's protocol ID
- 07-305
- Status last verified
- Jul 2017
- First submitted
- 30 Oct 2008
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Metabolic Near-infrared Tomographic Optical Breast Imaging (TOBI) to Monitor Response to Neoadjuvant Therapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT00783757
- Acronym / sponsor ID
- 07-305
- Conditions
- Breast Cancer
- Keywords
- neo-adjuvant chemotherapy, TOBI, breast imaging, optical imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Steven Isakoff, MD, PhDUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 3 Nov 2008 (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 research study is to see if Near-Infrared Tomographic Optical Breast Imaging (TOBI) scans can help monitor breast tumor response during treatment for breast cancer. The images created by the TOBI scan show changes in blood blow and oxygen levels in breast tissue.
Detailed description
- Participants will have a TOBI scan prior to starting their cancer treatment and again on day 8 after their first treatment. Participants will also be asked if they would volunteer to undergoing one or more additional TOBI scans on days 2-7 after they begin cancer treatment. These additional scans are optional. Participants will also have a scan on the first day of each treatment cycle.
- TOBI scans will be performed at the Gillette Center for Breast Cancer at the Massachusetts General Hospital.
- For the scan, each breast is placed between 2 plastic plates in order to spread the tissue apart, similar to the procedure for a mammogram. The TOBI scanner is attached to these plates. We will apply mild pressure to compress the breast and the breast will be scanned using light waves. Each scan will take about 3 minutes.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical Imaging | Experimental | Device: Optical ImagingTomographic Optical Imaging Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult female patients presenting to the MGH Cancer Center Gillette Center for breast cancer neoadjuvant therapy
- Subject who have had or will have a clinically indicated pre-treatment breast MRI
Key exclusion criteria (7 listed)
- Younger than 18 years of age
- Open wounds on breast
- Breast implants, because they may interfere with readings
- Subjects who will be receiving preoperative therapy for <28 days
- Breast surgery or biopsy < 10 days prior to optical imaging scan
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 |
|---|---|---|
| Optical ImagingAlso: TOBITOBI scan performed before the participant starts cancer treatment and at the start of each treatment cycle | Device | Optical Imaging |
Primary outcome
To explore the feasibility of measuring optically derived parameters in the clinical setting.
Time frame: 4 years
2 secondary outcomes
To explore the changes before and after neoadjuvant therapy of additional parameters derived from dynamic and static optical imaging of primary breast cancer.
Time frame: 4 years
To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer.
Time frame: 4 years
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 27 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Steven Isakoff, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Imaging in people with Breast Cancer, run by Steven Isakoff, MD, PhD 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 2 inclusion and 7 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 27 Jul 2017. 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.
What does the primary outcome measure?
To explore the feasibility of measuring optically derived parameters in the clinical setting. (time frame: 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 27 Jul 2017.