Breast NeoplasmsEarly Phase 1NCT04341129
Abbreviated MRI Protocol: Initial Experience With Dotarem® (Gadoterate Meglumine)
A Early Phase 1 study testing Abbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine) in people with Breast Neoplasms and Breast Diseases, run by University of Chicago at 1 site in United States.
Trial summary
Standard breast MRI studies often have lengthy protocols that make them inherently expensive and time-consuming. Several studies of the use of abbreviated MRI protocols have shown that the shorter protocols have diagnostic accuracy comparable to that of the conventional full MRI protocol. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Breast Diseases, Breast Fibroadenoma
- What is being tested?
- Abbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2020to 30 Jun 2023
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women between the ages of 18-80.
- Women with diagnostic imaging findings highly suspicious for breast cancer (BI-RADS category 4 or 5) or known breast cancer (BI-RADS category 6). Per BI-RADS lexicon, category 4 lesions carry a malignancy risk of 2-95% and category 5 lesions carry a malignancy risk of >95%.
Who cannot join
- Women with a history of adverse reactions to contrast media.
- Women with GFR below 30 mL/min/1.73m².
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Standard breast MRI studies often have lengthy protocols that make them inherently expensive and time-consuming. Several studies of the use of abbreviated MRI protocols have shown that the shorter protocols have diagnostic accuracy comparable to that of the conventional full MRI protocol. There are also promising results of ultrafast DCE-MRI studies with shorter breast MRI protocols that provide not only morphologic but also valuable kinetic information about a lesion. The shorter imaging times achieved with the abbreviated and the ultrafast DCE-MRI protocols have the potential to increase efficiency and lower cost by decreasing time in the MRI suite, which in turn may make breast MRI accessible for population-based mass screening. The focus of the proposed research is the investigation of an abbreviated MRI protocol with ultrafast imaging using Dotarem® (Gadoterate Meglumine).
Read the detailed description
Breast cancer is second to lung cancer as the leading cause of death among women in the United States. Over 40,000 women were estimated to die of breast cancer in 2016. Early detection is key to improved survival, and overall prognosis is directly linked to the stage of disease at the time of diagnosis. The 5-year relative survival rate has increased since the mid 1970's, in part owing to improvements in early breast cancer detection with screening mammography. Screening with mammography is associated with a 16-40% relative reduction in breast cancer mortality among women aged 40-74 years old, and mammography is the most cost-effective method of breast cancer screening. However, cancers can be missed at mammography, particularly in women with dense breasts. Screening with mammography alone may be insufficient in the screening of women who are at high risk of breast cancer. The need for more effective screening strategies to supplement mammography in these groups of women has led to the use of dynamic contrast-enhanced (DCE) breast MRI. Of the available modalities for evaluation of the breast, MRI has been found to have the highest sensitivity for the detection of breast cancer, irrespective of breast density.
On the basis of evidence from nonrandomized trials and observational studies, breast MRI is indicated as a supplement to mammography for patients at high risk with greater than 20% relative lifetime risk. This cohort of women includes those with: a known BRCA1 or BRCA2 genetic mutation, an approximately 20-25% or greater lifetime risk of breast cancer according to risk assessment tools, a strong family history of beast or ovarian cancer, a history of being treated for Hodgkin's disease and certain genetic syndromes (i.e. Li-Fraumeni syndrome, Cowden syndrome or Bannayan-Riley-Ruvalcaba syndrome). However, for women at intermediate risk, including those with dense breast tissue, screening MRI in the United States is not cost-effective. The cost-effectiveness of screening breast MRI depends on estimated breast cancer incidence and examination cost. The rationale for limiting supplemental screening breast MRI to those at greatest risk is in part due to its high cost.
Investigators have looked at ways of reducing the cost of breast MRI to improve access to it as a supplement screening method for women who are not necessarily in the highest risk group. One way to achieve the efficiency and rapid throughput found with screening mammography is to shorten screening breast MRI protocols, decrease image acquisition time, and shorten image interpretation time. Study results have suggested that shorter protocols and shorter acquisition times can be achieved with maintenance of diagnostic accuracy comparable to that obtained with conventional MRI protocols. Use of these abbreviated MRI protocols could result in lower cost and faster throughput, increasing availability and providing women with dense breasts or at intermediate risk (lifetime risk, 15-20%) greater access to breast MRI.
- Conditions
- Breast Neoplasms, Breast Diseases, Breast Fibroadenoma, Breast Cancer
- Being tested
- Abbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine)
- Keywords
- Breast, Breast Cancer, Invasive Ductal Cancer, Ductal Carcinoma in situ, Breast Neoplasm, Fibroadenoma
- Medical subject headings
- Breast Neoplasms, Breast Diseases, Fibroadenoma, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine)Drug
Also called Abbreviated MRI, Abbreviated MRI with Dotarem, Dotarem
To test the diagnostic effectiveness of an abbreviated MRI to a full MRI in the evaluation of breast lesions using Dotarem
| Study group | Role | What they receive |
|---|---|---|
| Abbreviated MRI using Dotarem | Experimental | Standard breast MRI studies often have lengthy protocols that make them inherently expensive and time-consuming. Several studies of the use of abbreviated MRI protocols have shown that the shorter protocols have diagnostic accuracy comparable to that of the conventional full MRI protocol. The shorter imaging times achieved with the abbreviated DCE-MRI protocols have the potential to increase efficiency and lower cost by decreasing time in the MRI suite, which in turn may make breast MRI accessible for population-based mass screening. The focus of the proposed research is the investigation of an abbreviated MRI protocol using Dotarem® (Gadoterate Meglumine) by comparing the diagnostic accuracy of dynamic contrast-enhanced breast MRIs performed with an abbreviated protocol versus a full protocol. Receives: Drug: Abbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the diagnostic accuracy of dynamic contrast-enhanced breast MRIs performed with an abbreviated protocol versus a full protocol
The abbreviated protocol will be generated from the full diagnostic protocol. It will comprise of a single unenhanced sequence and a single contrast-enhanced sequence. Subtraction images and a maximum intensity projection (MIP) image will be generated post-examination. The novel kinetic information obtained from the early contrast in combination with morphologic information from a high spatial resolution post-contrast scan, may provide unique dynamic parameters to effectively characterize and diagnose breast lesions on MR imaging.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start13 Jul 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Sponsor
- Investigators
- Hiroyuki Abe, MD, Principal investigator, University of Chicago Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341129
- Sponsor's protocol ID
- IRB19-2074
- Other IDs
- I002672
- Status last verified
- Dec 2023
- First submitted
- 26 Mar 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All study details, including study protocol, statistical analysis plan and informed consent plan, will be made available to all researchers through AURA (Automating University-wide Research Administration) -IRB and our electronic medical record.
Publications
Tabar L, Yen MF, Vitak B, Chen HH, Smith RA, Duffy SW. Mammography service screening and mortality in breast cancer patients: 20-year follow-up before and after introduction of screening. Lancet. 2003 Apr 26;361(9367):1405-10. doi: 10.1016/S0140-6736(03)13143-1.
PubMed 12727392Feig S. Cost-effectiveness of mammography, MRI, and ultrasonography for breast cancer screening. Radiol Clin North Am. 2010 Sep;48(5):879-91. doi: 10.1016/j.rcl.2010.06.002.
PubMed 20868891Nelson HD, O'Meara ES, Kerlikowske K, Balch S, Miglioretti D. Factors Associated With Rates of False-Positive and False-Negative Results From Digital Mammography Screening: An Analysis of Registry Data. Ann Intern Med. 2016 Feb 16;164(4):226-35. doi: 10.7326/M15-0971. Epub 2016 Jan 12.
PubMed 26756902Lee CH, Dershaw DD, Kopans D, Evans P, Monsees B, Monticciolo D, Brenner RJ, Bassett L, Berg W, Feig S, Hendrick E, Mendelson E, D'Orsi C, Sickles E, Burhenne LW. Breast cancer screening with imaging: recommendations from the Society of Breast Imaging and the ACR on the use of mammography, breast MRI, breast ultrasound, and other technologies for the detection of clinically occult breast cancer. J Am Coll Radiol. 2010 Jan;7(1):18-27. doi: 10.1016/j.jacr.2009.09.022.
PubMed 20129267Saslow D, Boetes C, Burke W, Harms S, Leach MO, Lehman CD, Morris E, Pisano E, Schnall M, Sener S, Smith RA, Warner E, Yaffe M, Andrews KS, Russell CA; American Cancer Society Breast Cancer Advisory Group. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin. 2007 Mar-Apr;57(2):75-89. doi: 10.3322/canjclin.57.2.75.
PubMed 17392385Moore SG, Shenoy PJ, Fanucchi L, Tumeh JW, Flowers CR. Cost-effectiveness of MRI compared to mammography for breast cancer screening in a high risk population. BMC Health Serv Res. 2009 Jan 13;9:9. doi: 10.1186/1472-6963-9-9.
PubMed 19144138Kuhl CK, Schrading S, Strobel K, Schild HH, Hilgers RD, Bieling HB. Abbreviated breast magnetic resonance imaging (MRI): first postcontrast subtracted images and maximum-intensity projection-a novel approach to breast cancer screening with MRI. J Clin Oncol. 2014 Aug 1;32(22):2304-10. doi: 10.1200/JCO.2013.52.5386. Epub 2014 Jun 23.
PubMed 24958821Mango VL, Morris EA, David Dershaw D, Abramson A, Fry C, Moskowitz CS, Hughes M, Kaplan J, Jochelson MS. Abbreviated protocol for breast MRI: are multiple sequences needed for cancer detection? Eur J Radiol. 2015 Jan;84(1):65-70. doi: 10.1016/j.ejrad.2014.10.004. Epub 2014 Oct 16.
PubMed 25454099Harvey SC, Di Carlo PA, Lee B, Obadina E, Sippo D, Mullen L. An Abbreviated Protocol for High-Risk Screening Breast MRI Saves Time and Resources. J Am Coll Radiol. 2016 Apr;13(4):374-80. doi: 10.1016/j.jacr.2015.08.015. Epub 2015 Oct 27.
PubMed 26521970Tsao J, Kozerke S. MRI temporal acceleration techniques. J Magn Reson Imaging. 2012 Sep;36(3):543-60. doi: 10.1002/jmri.23640.
PubMed 22903655Kuhl C. The current status of breast MR imaging. Part I. Choice of technique, image interpretation, diagnostic accuracy, and transfer to clinical practice. Radiology. 2007 Aug;244(2):356-78. doi: 10.1148/radiol.2442051620.
PubMed 17641361Kuhl CK. Current status of breast MR imaging. Part 2. Clinical applications. Radiology. 2007 Sep;244(3):672-91. doi: 10.1148/radiol.2443051661.
PubMed 17709824Kuhl CK, Schild HH, Morakkabati N. Dynamic bilateral contrast-enhanced MR imaging of the breast: trade-off between spatial and temporal resolution. Radiology. 2005 Sep;236(3):789-800. doi: 10.1148/radiol.2363040811.
PubMed 16118161Veltman J, Stoutjesdijk M, Mann R, Huisman HJ, Barentsz JO, Blickman JG, Boetes C. Contrast-enhanced magnetic resonance imaging of the breast: the value of pharmacokinetic parameters derived from fast dynamic imaging during initial enhancement in classifying lesions. Eur Radiol. 2008 Jun;18(6):1123-33. doi: 10.1007/s00330-008-0870-8. Epub 2008 Feb 13.
PubMed 18270714Mann RM, Mus RD, van Zelst J, Geppert C, Karssemeijer N, Platel B. A novel approach to contrast-enhanced breast magnetic resonance imaging for screening: high-resolution ultrafast dynamic imaging. Invest Radiol. 2014 Sep;49(9):579-85. doi: 10.1097/RLI.0000000000000057.
PubMed 24691143
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abbreviated MRI Protocol: Initial Experience With Dotarem® (Gadoterate Meglumine)
- ClinicalTrials.gov ID
- NCT04341129
- Acronym / sponsor ID
- IRB19-2074
- Conditions
- Breast Neoplasms, Breast Diseases, Breast Fibroadenoma, Breast Cancer
- Keywords
- Breast, Breast Cancer, Invasive Ductal Cancer, Ductal Carcinoma in situ, Breast Neoplasm, Fibroadenoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 10 Apr 2020 (actual)
- 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.
Standard breast MRI studies often have lengthy protocols that make them inherently expensive and time-consuming. Several studies of the use of abbreviated MRI protocols have shown that the shorter protocols have diagnostic accuracy comparable to that of the conventional full MRI protocol. There are also promising results of ultrafast DCE-MRI studies with shorter breast MRI protocols that provide not only morphologic but also valuable kinetic information about a lesion. The shorter imaging times achieved with the abbreviated and the ultrafast DCE-MRI protocols have the potential to increase efficiency and lower cost by decreasing time in the MRI suite, which in turn may make breast MRI accessible for population-based mass screening. The focus of the proposed research is the investigation of an abbreviated MRI protocol with ultrafast imaging using Dotarem® (Gadoterate Meglumine).
Detailed description
Breast cancer is second to lung cancer as the leading cause of death among women in the United States. Over 40,000 women were estimated to die of breast cancer in 2016. Early detection is key to improved survival, and overall prognosis is directly linked to the stage of disease at the time of diagnosis. The 5-year relative survival rate has increased since the mid 1970's, in part owing to improvements in early breast cancer detection with screening mammography. Screening with mammography is associated with a 16-40% relative reduction in breast cancer mortality among women aged 40-74 years old, and mammography is the most cost-effective method of breast cancer screening. However, cancers can be missed at mammography, particularly in women with dense breasts. Screening with mammography alone may be insufficient in the screening of women who are at high risk of breast cancer. The need for more effective screening strategies to supplement mammography in these groups of women has led to the use of dynamic contrast-enhanced (DCE) breast MRI. Of the available modalities for evaluation of the breast, MRI has been found to have the highest sensitivity for the detection of breast cancer, irrespective of breast density.
On the basis of evidence from nonrandomized trials and observational studies, breast MRI is indicated as a supplement to mammography for patients at high risk with greater than 20% relative lifetime risk. This cohort of women includes those with: a known BRCA1 or BRCA2 genetic mutation, an approximately 20-25% or greater lifetime risk of breast cancer according to risk assessment tools, a strong family history of beast or ovarian cancer, a history of being treated for Hodgkin's disease and certain genetic syndromes (i.e. Li-Fraumeni syndrome, Cowden syndrome or Bannayan-Riley-Ruvalcaba syndrome). However, for women at intermediate risk, including those with dense breast tissue, screening MRI in the United States is not cost-effective. The cost-effectiveness of screening breast MRI depends on estimated breast cancer incidence and examination cost. The rationale for limiting supplemental screening breast MRI to those at greatest risk is in part due to its high cost.
Investigators have looked at ways of reducing the cost of breast MRI to improve access to it as a supplement screening method for women who are not necessarily in the highest risk group. One way to achieve the efficiency and rapid throughput found with screening mammography is to shorten screening breast MRI protocols, decrease image acquisition time, and shorten image interpretation time. Study results have suggested that shorter protocols and shorter acquisition times can be achieved with maintenance of diagnostic accuracy comparable to that obtained with conventional MRI protocols. Use of these abbreviated MRI protocols could result in lower cost and faster throughput, increasing availability and providing women with dense breasts or at intermediate risk (lifetime risk, 15-20%) greater access to breast MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abbreviated MRI using Dotarem | Experimental | Drug: Abbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine)Standard breast MRI studies often have lengthy protocols that make them inherently expensive and time-consuming. Several studies of the use of abbreviated MRI protocols have shown that the shorter protocols have diagnostic accuracy comparable to that of the conventional full MRI protocol. The shorter imaging times achieved with the abbreviated DCE-MRI protocols have the potential to increase efficiency and lower cost by decreasing time in the MRI suite, which in turn may make breast MRI accessible for population-based mass screening. The focus of the proposed research is the investigation of an abbreviated MRI protocol using Dotarem® (Gadoterate Meglumine) by comparing the diagnostic accuracy of dynamic contrast-enhanced breast MRIs performed with an abbreviated protocol versus a full protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women between the ages of 18-80.
- Women with diagnostic imaging findings highly suspicious for breast cancer (BI-RADS category 4 or 5) or known breast cancer (BI-RADS category 6). Per BI-RADS lexicon, category 4 lesions carry a malignancy risk of 2-95% and category 5 lesions carry a malignancy risk of >95%.
Key exclusion criteria (2 listed)
- Women with a history of adverse reactions to contrast media.
- Women with GFR below 30 mL/min/1.73m².
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 |
|---|---|---|
| Abbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine)Also: Abbreviated MRI, Abbreviated MRI with Dotarem, DotaremTo test the diagnostic effectiveness of an abbreviated MRI to a full MRI in the evaluation of breast lesions using Dotarem | Drug | Abbreviated MRI using Dotarem |
Primary outcome
Compare the diagnostic accuracy of dynamic contrast-enhanced breast MRIs performed with an abbreviated protocol versus a full protocol
Time frame: one year
The abbreviated protocol will be generated from the full diagnostic protocol. It will comprise of a single unenhanced sequence and a single contrast-enhanced sequence. Subtraction images and a maximum intensity projection (MIP) image will be generated post-examination. The novel kinetic information obtained from the early contrast in combination with morphologic information from a high spatial resolution post-contrast scan, may provide unique dynamic parameters to effectively characterize and diagnose breast lesions on MR imaging.
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 5 Dec 2023.
- Background: PubMed 12727392Tabar L, Yen MF, Vitak B, Chen HH, Smith RA, Duffy SW. Mammography service screening and mortality in breast cancer patients: 20-year follow-up before and after introduction of screening. Lancet. 2003 Apr 26;361(9367):1405-10. doi: 10.1016/S0140-6736(03)13143-1.
- Background: PubMed 20868891Feig S. Cost-effectiveness of mammography, MRI, and ultrasonography for breast cancer screening. Radiol Clin North Am. 2010 Sep;48(5):879-91. doi: 10.1016/j.rcl.2010.06.002.
- Background: PubMed 26756902Nelson HD, O'Meara ES, Kerlikowske K, Balch S, Miglioretti D. Factors Associated With Rates of False-Positive and False-Negative Results From Digital Mammography Screening: An Analysis of Registry Data. Ann Intern Med. 2016 Feb 16;164(4):226-35. doi: 10.7326/M15-0971. Epub 2016 Jan 12.
- Background: PubMed 20129267Lee CH, Dershaw DD, Kopans D, Evans P, Monsees B, Monticciolo D, Brenner RJ, Bassett L, Berg W, Feig S, Hendrick E, Mendelson E, D'Orsi C, Sickles E, Burhenne LW. Breast cancer screening with imaging: recommendations from the Society of Breast Imaging and the ACR on the use of mammography, breast MRI, breast ultrasound, and other technologies for the detection of clinically occult breast cancer. J Am Coll Radiol. 2010 Jan;7(1):18-27. doi: 10.1016/j.jacr.2009.09.022.
- Background: PubMed 17392385Saslow D, Boetes C, Burke W, Harms S, Leach MO, Lehman CD, Morris E, Pisano E, Schnall M, Sener S, Smith RA, Warner E, Yaffe M, Andrews KS, Russell CA; American Cancer Society Breast Cancer Advisory Group. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin. 2007 Mar-Apr;57(2):75-89. doi: 10.3322/canjclin.57.2.75.
- Background: PubMed 19144138Moore SG, Shenoy PJ, Fanucchi L, Tumeh JW, Flowers CR. Cost-effectiveness of MRI compared to mammography for breast cancer screening in a high risk population. BMC Health Serv Res. 2009 Jan 13;9:9. doi: 10.1186/1472-6963-9-9.
- Background: PubMed 24958821Kuhl CK, Schrading S, Strobel K, Schild HH, Hilgers RD, Bieling HB. Abbreviated breast magnetic resonance imaging (MRI): first postcontrast subtracted images and maximum-intensity projection-a novel approach to breast cancer screening with MRI. J Clin Oncol. 2014 Aug 1;32(22):2304-10. doi: 10.1200/JCO.2013.52.5386. Epub 2014 Jun 23.
- Background: PubMed 25454099Mango VL, Morris EA, David Dershaw D, Abramson A, Fry C, Moskowitz CS, Hughes M, Kaplan J, Jochelson MS. Abbreviated protocol for breast MRI: are multiple sequences needed for cancer detection? Eur J Radiol. 2015 Jan;84(1):65-70. doi: 10.1016/j.ejrad.2014.10.004. Epub 2014 Oct 16.
- Background: PubMed 26521970Harvey SC, Di Carlo PA, Lee B, Obadina E, Sippo D, Mullen L. An Abbreviated Protocol for High-Risk Screening Breast MRI Saves Time and Resources. J Am Coll Radiol. 2016 Apr;13(4):374-80. doi: 10.1016/j.jacr.2015.08.015. Epub 2015 Oct 27.
- Background: PubMed 22903655Tsao J, Kozerke S. MRI temporal acceleration techniques. J Magn Reson Imaging. 2012 Sep;36(3):543-60. doi: 10.1002/jmri.23640.
- Background: PubMed 17641361Kuhl C. The current status of breast MR imaging. Part I. Choice of technique, image interpretation, diagnostic accuracy, and transfer to clinical practice. Radiology. 2007 Aug;244(2):356-78. doi: 10.1148/radiol.2442051620.
- Background: PubMed 17709824Kuhl CK. Current status of breast MR imaging. Part 2. Clinical applications. Radiology. 2007 Sep;244(3):672-91. doi: 10.1148/radiol.2443051661.
- American Cancer Society website. Cancer facts and figures 2016Link provided by the sponsor.
- National Cancer Institute website. SEER stat fact sheets:female breast cancerLink provided by the sponsor.
- American College of Radiology website. ACR Appropriateness Criteria: breast cancer screening. Date of origin 2012. Last review date 2016.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All study details, including study protocol, statistical analysis plan and informed consent plan, will be made available to all researchers through AURA (Automating University-wide Research Administration) -IRB and our electronic medical record.
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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.
Hiroyuki Abe, MD principal investigator
University of Chicago Medicine
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 Abbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine) in people with Breast Neoplasms and Breast Diseases, run by University of Chicago 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 2 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 5 Dec 2023. 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 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?
Compare the diagnostic accuracy of dynamic contrast-enhanced breast MRIs performed with an abbreviated protocol versus a full protocol (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04341129, which also lists 17 linked publications.
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 5 Dec 2023.