Breast CancerEarly Phase 1NCT02380209
An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer
A Early Phase 1 study testing CEST MRI in people with Breast Cancer, run by University of Arizona at 1 site in United States.
Trial summary
Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis. 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?
- CEST MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 2016
- Phase
- Early Phase 1
- 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
- Newly diagnosed infiltrating ductal carcinoma (IDC) of the breast
- >= 1.0 cm primary tumor
- Calculated creatinine clearance >= 50 mL/min
- Willing and able to provide informed consent
- Age ≥ 18 years
- ECOG performance status 0-2
- Informed of the investigational nature of this study
Who cannot join
- Allergy to iodinated contrast agent
- Use of metformin, aminoglycosides, other nephrotoxic medications, or daily use of NSAIDs
- Diabetes mellitus
- History of severe claustrophobia
- Presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude MRI
- Use of > 1 antihypertensive drug
Show all 11Show fewer
- Pregnancy or breastfeeding
- Paraproteinemia syndromes or multiple myeloma
- Collagen vascular disease
- Active hyperthyroidism
- Active pharmaceutical treatments for cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Cancer Center at UMC North
Tucson, Arizona, 85724
About this study
Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis.
Read the detailed description
Those involved in the treatment of patients with breast cancer have pioneered the field of personalized cancer therapy through the use of targeted therapies and their associated biomarkers. Assays to quantify tumor acidosis and hypoxia are hypothesized to potentially represent such biomarkers. However there is currently no gold standard for measuring either.
This trial will evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe), to a clinical MRI scanner in women with early stage breast cancer. This trial will generate preliminary data regarding the feasibility of this imaging technique. If successful, in future studies CEST MRI may serve as an imaging biomarker for acidosis and hypoxia.
- Conditions
- Breast Cancer
- Being tested
- CEST MRI
- Keywords
- breast cancer, CEST MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEST MRIOther
Also called iopromide, Ultravist, Isovue
CEST MRI will be performed on patients prior to surgical resection of their tumor
| Study group | Role | What they receive |
|---|---|---|
| Optimization | Experimental | CEST MRI of the breast for estimation of tumor pH. Receives: Other: CEST MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH measurement of the tumor will be measured by the CEST MRI.
pH estimate of the tumor
Measured: 2 weeks
Secondary outcomes (1)
Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: PI has terminated study as the sequencing on patients and volunteers didn't yield the results expected. PI has no plans for scholarly/scientific presentations.
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.
- More trials run by University of ArizonaThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavani Chalasani, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380209
- Sponsor's protocol ID
- 1406349968
- Status last verified
- Oct 2016
- First submitted
- 9 Jan 2015
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02380209
- Acronym / sponsor ID
- 1406349968
- Conditions
- Breast Cancer
- Keywords
- breast cancer, CEST MRI
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI has terminated study as the sequencing on patients and volunteers didn't yield the results expected. PI has no plans for scholarly/scientific presentations.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Mar 2015 (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.
Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis.
Detailed description
Those involved in the treatment of patients with breast cancer have pioneered the field of personalized cancer therapy through the use of targeted therapies and their associated biomarkers. Assays to quantify tumor acidosis and hypoxia are hypothesized to potentially represent such biomarkers. However there is currently no gold standard for measuring either.
This trial will evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe), to a clinical MRI scanner in women with early stage breast cancer. This trial will generate preliminary data regarding the feasibility of this imaging technique. If successful, in future studies CEST MRI may serve as an imaging biomarker for acidosis and hypoxia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optimization | Experimental | Other: CEST MRICEST MRI of the breast for estimation of tumor pH. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed infiltrating ductal carcinoma (IDC) of the breast
- >= 1.0 cm primary tumor
- Calculated creatinine clearance >= 50 mL/min
- Willing and able to provide informed consent
- Age ≥ 18 years
Key exclusion criteria (11 listed)
- Allergy to iodinated contrast agent
- Use of metformin, aminoglycosides, other nephrotoxic medications, or daily use of NSAIDs
- Diabetes mellitus
- History of severe claustrophobia
- Presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude MRI
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 |
|---|---|---|
| CEST MRIAlso: iopromide, Ultravist, IsovueCEST MRI will be performed on patients prior to surgical resection of their tumor | Other | Optimization |
Primary outcome
pH measurement of the tumor will be measured by the CEST MRI.
Time frame: 2 weeks
pH estimate of the tumor
1 secondary outcome
Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: PI has terminated study as the sequencing on patients and volunteers didn't yield the results expected. PI has no plans for scholarly/scientific presentations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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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.
Pavani Chalasani, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CEST MRI in people with Breast Cancer, run by University of Arizona 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 7 inclusion and 11 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 27 Oct 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI has terminated study as the sequencing on patients and volunteers didn't yield the results expected. PI has no plans for scholarly/scientific presentations.). 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?
pH measurement of the tumor will be measured by the CEST MRI. (time frame: 2 weeks). 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 Oct 2016.