Atypical Ductal HyperplasiaNCT03505372
Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia
A study testing Contrast enhanced mammography in people with Atypical Ductal Hyperplasia, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is studying whether contrast enhanced mammography can predict if atypical ductal hyperplasia will progress to cancer. The device involved in this study is: -Contrast enhanced mammography Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Atypical Ductal Hyperplasia
- What is being tested?
- Contrast enhanced mammography
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2018to 28 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age, Minimum 30 years. CESM is an imaging exam that uses radiation and is not typically employed in women younger than age 30 due to potentially negative biologic effects on glandular breast tissue.
- Participants who had a percutaneous breast biopsy (to include stereotactic, tomosynthesis, or ultrasound guided) that revealed ADH
- Participants will be undergoing surgical excision to remove the ADH.
- Participants must have normal organ and marrow function as defined by a GFR ≥60 mL/min/1.73 m2 to be performed per clinical protocol
- Patients ≥65 years without underlying renal insufficiency get GFR tested within 6 months of the exam.
- Patients < 65 years without underlying renal insufficiency do not require an GFR calculation)
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- Patients ≥65 years with known underlying renal insufficiency get GFR tested within 1 month of the exam.
- Patients < 65 years with known renal insufficiency get GFR tested within 1 month of the exam.
- Because of the potential teratogenic effects of radiation, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, until the CESM is performed. Should a woman become pregnant or suspect she is pregnant, she should inform the study team prior to getting the CESM.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Participants with a core biopsy diagnosis of atypia with associated malignancy (in the same quadrant) will be excluded.
- Participant had a breast MRI that was performed after the diagnosis of ADH but before surgical excision
- Participants who have a known allergy to contrast media.
- Participants who have a known severe allergic response to one or more allergens, as defined by anaphylaxis.
- Participants with persistent asthma as defined by the National Heart, Lung, and Blood Institute.
- Participants with renal insufficiency or failure, as determined by a point of care renal function blood test.
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- Participants who are breastfeeding are excluded because there is an unknown but potential risk for adverse events in nursing infants secondary to contrast administration in the mother.
- Participants with the following underlying medical conditions: multiple myeloma, myasthenia gravis, dysproteinemias, severe cardiac disease, aortic stenosis, primary pulmonary hypertension, cardiac arrythmia, or severe cardiomyopathy. These underlying medical conditions may make the participant more likely to develop a contrast reaction. This is based on the ACR contrast manual version 10.3 and hospital policy.
- Participants with thyroid carcinoma or thyroid disease for whom systemic radioactive iodine therapy is part of planned diagnostic work-up or treatment within 2 months following the contrast mammogram study.
- Participants with a concurrent active illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, thyroid storm.
- Pregnant women are excluded from this study because CESM uses radiation with the potential for teratogenic or abortifacient effects. This will be defined by a urine pregnancy test prior to the CESM study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
This research study is studying whether contrast enhanced mammography can predict if atypical ductal hyperplasia will progress to cancer.
The device involved in this study is:
-Contrast enhanced mammography
Read the detailed description
This research study is a Pilot Study, which is the first time investigators are examining this study device for this purpose.
Atypical ductal hyperplasia (ADH) is a common diagnosis after breast biopsy. Although it is not cancer itself, ADH can become breast cancer in some cases. As a result, surgery is performed to remove ADH to make sure it doesn't progress to cancer. In many cases, no cancer is found during the surgery.
Previous studies have shown that breast MRI may be able to predict which areas of ADH will be cancer at the time of surgery. This would help prevent unnecessary surgery in some patients.
Contrast enhanced mammography is a new type of mammogram that is already being used in clinical practice to help find breast cancer. Similar to breast MRI, it uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. Contrast material is a dye or other substance that helps show abnormal areas within the body.
Studies have shown the contrast enhanced mammography has a similar ability to find breast cancer as breast MRI.
The investigators purpose is to see whether contrast enhanced mammography can predict which areas of ADH will become breast cancer at the time of surgery. The investigators believe this will help prevent unnecessary surgery in many with women with the diagnosis of ADH.
- Conditions
- Atypical Ductal Hyperplasia
- Being tested
- Contrast enhanced mammography
- Keywords
- Atypical ductal hyperplasia, ADH
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast enhanced mammographyDevice
Contrast enhanced mammography is a new type of mammogram that uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone.
| Study group | Role | What they receive |
|---|---|---|
| Contrast enhanced mammography | Experimental | * The CESM images will be performed according to clinical protocol
* Images will be acquired within approximately 2-12 minutes of contrast injection
* A total of four images per breast will be acquired with low and high energy
* Two radiologists will prospectively review the CESM, and will use a third as tie-breaker
* The CESM will be evaluated for the biopsy site and up to two additional findings in either breast
* The biopsy site will be evaluated for abnormal findings that would suggest malignant involvement Receives: Device: Contrast enhanced mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
CESM's Ability to Predict Upgrade Rates of Biopsy Proven ADH at Surgical Excision
Investigators will evaluate whether enhancement on CESM can predict which cases of ADH upgrade at the time of surgical excision.
Measured: 3 months
Secondary outcomes (1)
Types of Changes in Surgical Management Based on CESM
Investigators will evaluate how incidental findings seen on CESM impact the surgical management of patients diagnosed with ADH. The initial surgical management documented in the clinical report (created before CESM performed) will be compared with the surgical management documented in the medical record after the CESM was performed to determine the change.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start10 May 2018
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Why it stopped: Unable to recruit to study due to limited number of patients with ADH
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atypical Ductal HyperplasiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Jordana Phillips, MD, Dana-Farber Cancer Institute
- Investigators
- Jordana Phillips, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505372
- Sponsor's protocol ID
- 17-694
- Status last verified
- Jan 2020
- First submitted
- 4 Apr 2018
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia
- ClinicalTrials.gov ID
- NCT03505372
- Acronym / sponsor ID
- 17-694
- Conditions
- Atypical Ductal Hyperplasia
- Keywords
- Atypical ductal hyperplasia, ADH
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit to study due to limited number of patients with ADH
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 10 May 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Posted 11 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying whether contrast enhanced mammography can predict if atypical ductal hyperplasia will progress to cancer.
The device involved in this study is:
-Contrast enhanced mammography
Detailed description
This research study is a Pilot Study, which is the first time investigators are examining this study device for this purpose.
Atypical ductal hyperplasia (ADH) is a common diagnosis after breast biopsy. Although it is not cancer itself, ADH can become breast cancer in some cases. As a result, surgery is performed to remove ADH to make sure it doesn't progress to cancer. In many cases, no cancer is found during the surgery.
Previous studies have shown that breast MRI may be able to predict which areas of ADH will be cancer at the time of surgery. This would help prevent unnecessary surgery in some patients.
Contrast enhanced mammography is a new type of mammogram that is already being used in clinical practice to help find breast cancer. Similar to breast MRI, it uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. Contrast material is a dye or other substance that helps show abnormal areas within the body.
Studies have shown the contrast enhanced mammography has a similar ability to find breast cancer as breast MRI.
The investigators purpose is to see whether contrast enhanced mammography can predict which areas of ADH will become breast cancer at the time of surgery. The investigators believe this will help prevent unnecessary surgery in many with women with the diagnosis of ADH.
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 mammography | Experimental | Device: Contrast enhanced mammography* The CESM images will be performed according to clinical protocol * Images will be acquired within approximately 2-12 minutes of contrast injection * A total of four images per breast will be acquired with low and high energy * Two radiologists will prospectively review the CESM, and will use a third as tie-breaker * The CESM will be evaluated for the biopsy site and up to two additional findings in either breast * The biopsy site will be evaluated for abnormal findings that would suggest malignant involvement |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age, Minimum 30 years. CESM is an imaging exam that uses radiation and is not typically employed in women younger than age 30 due to potentially negative biologic effects on glandular breast tissue.
- Participants who had a percutaneous breast biopsy (to include stereotactic, tomosynthesis, or ultrasound guided) that revealed ADH
- Participants will be undergoing surgical excision to remove the ADH.
- Participants must have normal organ and marrow function as defined by a GFR ≥60 mL/min/1.73 m2 to be performed per clinical protocol
- Patients ≥65 years without underlying renal insufficiency get GFR tested within 6 months of the exam.
Key exclusion criteria (11 listed)
- Participants with a core biopsy diagnosis of atypia with associated malignancy (in the same quadrant) will be excluded.
- Participant had a breast MRI that was performed after the diagnosis of ADH but before surgical excision
- Participants who have a known allergy to contrast media.
- Participants who have a known severe allergic response to one or more allergens, as defined by anaphylaxis.
- Participants with persistent asthma as defined by the National Heart, Lung, and Blood Institute.
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 mammographyContrast enhanced mammography is a new type of mammogram that uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. | Device | Contrast enhanced mammography |
Primary outcome
CESM's Ability to Predict Upgrade Rates of Biopsy Proven ADH at Surgical Excision
Time frame: 3 months
Investigators will evaluate whether enhancement on CESM can predict which cases of ADH upgrade at the time of surgical excision.
1 secondary outcome
Types of Changes in Surgical Management Based on CESM
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jordana Phillips, MD principal investigator
Beth Israel Deaconess Medical 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 mammography in people with Atypical Ductal Hyperplasia, run by Dana-Farber Cancer Institute 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 10 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 11 Feb 2020. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CESM's Ability to Predict Upgrade Rates of Biopsy Proven ADH at Surgical Excision (time frame: 3 months). 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 11 Feb 2020.