NCT04498611 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Baxter GC, Graves MJ, Gilbert FJ, Patterson AJ
A Meta-analysis of the Diagnostic Performance of Diffusion MRI for Breast Lesion Characterization. Radiology. 2019 Jun;291(3):632-641. doi: 10.1148/radiol.2019182510. Epub 2019 Apr 23.
Borlinhas F, Conceição RC, Ferreira HA
Optimal b-values for diffusion kurtosis imaging in invasive ductal carcinoma versus ductal carcinoma in situ breast lesions. Australas Phys Eng Sci Med. 2019 Sep;42(3):871-885. doi: 10.1007/s13246-019-00773-2. Epub 2019 Jul 18.
Lamb LR, Lehman CD, Oseni TO, Bahl M
Ductal Carcinoma In Situ (DCIS) at Breast MRI: Predictors of Upgrade to Invasive Carcinoma. Acad Radiol. 2020 Oct;27(10):1394-1399. doi: 10.1016/j.acra.2019.09.025. Epub 2019 Nov 4.
Lee KH, Han JW, Kim EY, Yun JS, Park YL, Park CH
Predictive factors for the presence of invasive components in patients diagnosed with ductal carcinoma in situ based on preoperative biopsy. BMC Cancer. 2019 Dec 10;19(1):1201. doi: 10.1186/s12885-019-6417-3.
Mori N, Ota H, Mugikura S, Takasawa C, Tominaga J, Ishida T, Watanabe M, Takase K, Takahashi S
Detection of invasive components in cases of breast ductal carcinoma in situ on biopsy by using apparent diffusion coefficient MR parameters. Eur Radiol. 2013 Oct;23(10):2705-12. doi: 10.1007/s00330-013-2902-2. Epub 2013 Jun 4.
Surov A, Meyer HJ, Wienke A
Can apparent diffusion coefficient (ADC) distinguish breast cancer from benign breast findings? A meta-analysis based on 13 847 lesions. BMC Cancer. 2019 Oct 15;19(1):955. doi: 10.1186/s12885-019-6201-4.

Prediction of Upgrade to Invasive Cancer in Patients Diagnosed With Ductal Carcinoma in Situ by Percutaneous Core Needle Biopsy: A Development and Validation Study

Details for clinical trial NCT04498611

Clinical trial NCT04498611 - References