Breast AbnormalitiesNCT02406274
Use of Contrast Enhanced Spectral Mammography (CESM) for Women With Palpable Breast Abnormalities
A study testing Contrast Enhanced Spectral Mammography (CESM) in people with Breast Abnormalities, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Contrast Enhanced Spectral Mammography (CESM) is an advanced form of mammography which is performed after injection of contrast or dye into a vein in the arm. This dye is the same dye that is used for CT scans. This type of mammogram includes a regular mammogram as well as additional pictures with the dye. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Breast Abnormalities
- What is being tested?
- Contrast Enhanced Spectral Mammography (CESM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 27 Jun 2024
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women presenting for mammographic evaluation of an undiagnosed palpable mass found either by self examination and/or examination by referring physician
Who cannot join
- Age < 25 years old
- Male patients
- Pregnant or lactating patients
- Patients with allergy to iodinated contrast
- Patients with a history of renal disease or patients over 70 with a creatinine > 1.3. Creatinine must have been done within the last 12 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Contrast Enhanced Spectral Mammography (CESM) is an advanced form of mammography which is performed after injection of contrast or dye into a vein in the arm. This dye is the same dye that is used for CT scans. This type of mammogram includes a regular mammogram as well as additional pictures with the dye.
This particular study is being done to determine if by adding the dye in the veins the investigators are better able to identify the cause of the lump than if they just did the regular mammogram alone.
- Conditions
- Breast Abnormalities
- Being tested
- Contrast Enhanced Spectral Mammography (CESM)
- Keywords
- Mammography, Contrast Enhanced Spectral Mammography, Palpable Breast Abnormalities, 15-053
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Enhanced Spectral Mammography (CESM)Other
Women presenting to MSKCC with a palpable abnormality within the breast either self palpated \& or palpated by their physician will be offered CESM instead of FFDM alone. The breast imager assigned to care for the patient will interpret the low energy images (including any additional views they routinely obtain) \& record their findings. They will then interpret the CESM \& record those results. As per standard of care, the patient will have a targeted ultrasound as well. Appropriate clinical recommendations will be made. In patients with no specific imaging findings, follow-up will be determined by the degree of suspicion of the palpable finding \& will either be called negative \& followed clinically if not suspicious, or will go on to MRI , percutaneous biopsy by a surgeon or surgical biopsy if suspicious.
| Study group | Role | What they receive |
|---|---|---|
| Contrast Enhanced Spectral Mammography | Experimental | Not described Receives: Other: Contrast Enhanced Spectral Mammography (CESM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive predictive value
(PPV) will be defined using three distinct definitions: (1) PPV1 is the proportion of women with a positive assessment who had a cancer diagnosis in the follow-up period. (2) PPV2 is the proportion of women with a recommendation for biopsy who had a cancer diagnosis in the follow-up period. (3) PPV3 is the proportion of women with a biopsy recommendation and a biopsy performed within 1 year who had a cancer diagnosis in the follow-up period. Negative predictive value (NPV) is the proportion of women with a negative assessment who did not have a cancer diagnosis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startMar 2015
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxine Jochelson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406274
- Sponsor's protocol ID
- 15-053
- Status last verified
- Jun 2024
- First submitted
- 30 Mar 2015
- Last updated
- 28 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Contrast Enhanced Spectral Mammography (CESM) for Women With Palpable Breast Abnormalities
- ClinicalTrials.gov ID
- NCT02406274
- Acronym / sponsor ID
- 15-053
- Conditions
- Breast Abnormalities
- Keywords
- Mammography, Contrast Enhanced Spectral Mammography, Palpable Breast Abnormalities, 15-053
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 2 Apr 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.
Contrast Enhanced Spectral Mammography (CESM) is an advanced form of mammography which is performed after injection of contrast or dye into a vein in the arm. This dye is the same dye that is used for CT scans. This type of mammogram includes a regular mammogram as well as additional pictures with the dye.
This particular study is being done to determine if by adding the dye in the veins the investigators are better able to identify the cause of the lump than if they just did the regular mammogram alone.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast Enhanced Spectral Mammography | Experimental | Other: Contrast Enhanced Spectral Mammography (CESM) |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women presenting for mammographic evaluation of an undiagnosed palpable mass found either by self examination and/or examination by referring physician
Key exclusion criteria (5 listed)
- Age < 25 years old
- Male patients
- Pregnant or lactating patients
- Patients with allergy to iodinated contrast
- Patients with a history of renal disease or patients over 70 with a creatinine > 1.3. Creatinine must have been done within the last 12 weeks.
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 |
|---|---|---|
| Contrast Enhanced Spectral Mammography (CESM)Women presenting to MSKCC with a palpable abnormality within the breast either self palpated \& or palpated by their physician will be offered CESM instead of FFDM alone. The breast imager assigned to care for the patient will interpret the low energy images (including any additional views they routinely obtain) \& record their findings. They will then interpret the CESM \& record those results. As per standard of care, the patient will have a targeted ultrasound as well. Appropriate clinical recommendations will be made. In patients with no specific imaging findings, follow-up will be determined by the degree of suspicion of the palpable finding \& will either be called negative \& followed clinically if not suspicious, or will go on to MRI , percutaneous biopsy by a surgeon or surgical biopsy if suspicious. | Other | Contrast Enhanced Spectral Mammography |
Primary outcome
positive predictive value
Time frame: 1 year
(PPV) will be defined using three distinct definitions: (1) PPV1 is the proportion of women with a positive assessment who had a cancer diagnosis in the follow-up period. (2) PPV2 is the proportion of women with a recommendation for biopsy who had a cancer diagnosis in the follow-up period. (3) PPV3 is the proportion of women with a biopsy recommendation and a biopsy performed within 1 year who had a cancer diagnosis in the follow-up period. Negative predictive value (NPV) is the proportion of women with a negative assessment who did not have a cancer diagnosis.
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 28 Jun 2024.
- Memorial Sloan Kettering Cancer CenterLink 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.
Maxine Jochelson, MD principal investigator
Memorial Sloan Kettering 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 Contrast Enhanced Spectral Mammography (CESM) in people with Breast Abnormalities, run by Memorial Sloan Kettering 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 1 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: finished, as of the sponsor's last update on 28 Jun 2024. 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?
positive predictive value (time frame: 1 year). 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 28 Jun 2024.