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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-08950 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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To create a registry (database) of participants who come in for breast MRI scans. Researchers want to use this information to study if participants with dense breast tissue (tissue that is more difficult to see on mammogram).
Primary Objectives
- To determine the number of false positive biopsies obtained from surveillance MRI in participant with personal history of breast cancer, age 50 or under, and mammographically dense breasts.
Secondary Objectives
I. To determine the incidence of interval cancer.
II. To compare participants with personal history of breast cancer, age 50 and under, who did not receive surveillance MRI.
III. To determine positive predictive value (PPV) and negative predictive value (NPV) of surveillance breast MRI in this population.
IV. To compare the tumor biology of breast cancer detected on breast MRI.
V. To determine the participants experience with MRI i.e. willingness to return for testing with breast MRI.
VI. To evaluate the reasons women refuse breast MRI for the surveillance of recurrent disease or secondary breast cancer.
VII. To determine the patients' interest in having procedural hypnosis to improve patient reported acceptance of breast MRI among participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Questionnaire/Interview | Participants will take part in this study, before and after your routine breast MRI scan, participants will be asked to answer a series of questions about your experience with this MRI. It may take 10 to 20 minutes to answer. Participants may answer these questions in 1 of 3 ways:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire/Interview | Behavioral | Participation on this study will be over as soon as you complete the questionnaire/interview after your scheduled scans. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | through study completion; an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Estimate sample size of 1000 patients, with accrual rate of 250 patients per year
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huong Le-Petross, MD | Contact | 713-563-7827 | hlepetross@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Huong Le-Petross, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |