Clinical trial NCT03257839 - References

Breast Neoplasms — Delphinus SoftVue Prospective Case Collection - ARM 1

Citation(s)

•   Berg WA, Blume JD, Cormack JB, Mendelson EB, Lehrer D, Böhm-Vélez M, Pisano ED, Jong RA, Evans WP, Morton MJ, Mahoney MC, Larsen LH, Barr RG, Farria DM, Marques HS, Boparai K; ACRIN 6666 Investigators
  Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer. JAMA. 2008 May 14;299(18):2151-63. doi: 10.1001/jama.299.18.2151. Erratum in: JAMA. 2010 Apr 21;303(15):1482.
•   Berg WA, Blume JD, Cormack JB, Mendelson EB
  Operator dependence of physician-performed whole-breast US: lesion detection and characterization. Radiology. 2006 Nov;241(2):355-65.
•   Berg WA, Zhang Z, Lehrer D, Jong RA, Pisano ED, Barr RG, Böhm-Vélez M, Mahoney MC, Evans WP 3rd, Larsen LH, Morton MJ, Mendelson EB, Farria DM, Cormack JB, Marques HS, Adams A, Yeh NM, Gabrielli G; ACRIN 6666 Investigators
  Detection of breast cancer with addition of annual screening ultrasound or a single screening MRI to mammography in women with elevated breast cancer risk. JAMA. 2012 Apr 4;307(13):1394-404. doi: 10.1001/jama.2012.388.
•   Boyd NF, Guo H, Martin LJ, Sun L, Stone J, Fishell E, Jong RA, Hislop G, Chiarelli A, Minkin S, Yaffe MJ
  Mammographic density and the risk and detection of breast cancer. N Engl J Med. 2007 Jan 18;356(3):227-36.
•   Boyd NF, Martin LJ, Yaffe MJ, Minkin S
  Mammographic density: a hormonally responsive risk factor for breast cancer. J Br Menopause Soc. 2006 Dec;12(4):186-93. Review.
•   Brem RF, Tabár L, Duffy SW, Inciardi MF, Guingrich JA, Hashimoto BE, Lander MR, Lapidus RL, Peterson MK, Rapelyea JA, Roux S, Schilling KJ, Shah BA, Torrente J, Wynn RT, Miller DP
  Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue: the SomoInsight Study. Radiology. 2015 Mar;274(3):663-73. doi: 10.1148/radiol.14132832. Epub 2014 Oct 17.
•   Buchberger W, Niehoff A, Obrist P, DeKoekkoek-Doll P, Dünser M
  Clinically and mammographically occult breast lesions: detection and classification with high-resolution sonography. Semin Ultrasound CT MR. 2000 Aug;21(4):325-36.
•   Checka CM, Chun JE, Schnabel FR, Lee J, Toth H
  The relationship of mammographic density and age: implications for breast cancer screening. AJR Am J Roentgenol. 2012 Mar;198(3):W292-5. doi: 10.2214/AJR.10.6049.
•   Cole EB, Pisano ED, Kistner EO, Muller KE, Brown ME, Feig SA, Jong RA, Maidment AD, Staiger MJ, Kuzmiak CM, Freimanis RI, Lesko N, Rosen EL, Walsh R, Williford M, Braeuning MP
  Diagnostic accuracy of digital mammography in patients with dense breasts who underwent problem-solving mammography: effects of image processing and lesion type. Radiology. 2003 Jan;226(1):153-60.
•   Corsetti V, Ferrari A, Ghirardi M, Bergonzini R, Bellarosa S, Angelini O, Bani C, Ciatto S
  Role of ultrasonography in detecting mammographically occult breast carcinoma in women with dense breasts. Radiol Med. 2006 Apr;111(3):440-8. Epub 2006 Apr 11. English, Italian.
•   Corsetti V, Houssami N, Ferrari A, Ghirardi M, Bellarosa S, Angelini O, Bani C, Sardo P, Remida G, Galligioni E, Ciatto S
  Breast screening with ultrasound in women with mammography-negative dense breasts: evidence on incremental cancer detection and false positives, and associated cost. Eur J Cancer. 2008 Mar;44(4):539-44. doi: 10.1016/j.ejca.2008.01.009. Epub 2008 Feb 11.
•   Crystal P, Strano SD, Shcharynski S, Koretz MJ
  Using sonography to screen women with mammographically dense breasts. AJR Am J Roentgenol. 2003 Jul;181(1):177-82.
•   Duffy SW, Smith RA, Gabe R, Tabár L, Yen AM, Chen TH
  Screening for breast cancer. Surg Oncol Clin N Am. 2005 Oct;14(4):671-97. Review.
•   Duffy SW, Tabár L, Chen HH, Holmqvist M, Yen MF, Abdsalah S, Epstein B, Frodis E, Ljungberg E, Hedborg-Melander C, Sundbom A, Tholin M, Wiege M, Akerlund A, Wu HM, Tung TS, Chiu YH, Chiu CP, Huang CC, Smith RA, Rosén M, Stenbeck M, Holmberg L
  The impact of organized mammography service screening on breast carcinoma mortality in seven Swedish counties. Cancer. 2002 Aug 1;95(3):458-69.
•   Gordon PB, Goldenberg SL
  Malignant breast masses detected only by ultrasound. A retrospective review. Cancer. 1995 Aug 15;76(4):626-30.
•   Haas BM, Kalra V, Geisel J, Raghu M, Durand M, Philpotts LE
  Comparison of tomosynthesis plus digital mammography and digital mammography alone for breast cancer screening. Radiology. 2013 Dec;269(3):694-700. doi: 10.1148/radiol.13130307. Epub 2013 Oct 28.
•   Hakama M, Pukkala E, Heikkilä M, Kallio M
  Effectiveness of the public health policy for breast cancer screening in Finland: population based cohort study. BMJ. 1997 Mar 22;314(7084):864-7.
•   Hooley RJ, Greenberg KL, Stackhouse RM, Geisel JL, Butler RS, Philpotts LE
  Screening US in patients with mammographically dense breasts: initial experience with Connecticut Public Act 09-41. Radiology. 2012 Oct;265(1):59-69. Epub 2012 Jun 21.
•   Houssami N, Irwig L, Ciatto S
  Radiological surveillance of interval breast cancers in screening programmes. Lancet Oncol. 2006 Mar;7(3):259-65. Review.
•   Kaplan SS
  Clinical utility of bilateral whole-breast US in the evaluation of women with dense breast tissue. Radiology. 2001 Dec;221(3):641-9.
•   Kelly KM, Dean J, Comulada WS, Lee SJ
  Breast cancer detection using automated whole breast ultrasound and mammography in radiographically dense breasts. Eur Radiol. 2010 Mar;20(3):734-42. doi: 10.1007/s00330-009-1588-y. Epub 2009 Sep 2.
•   Kerlikowske K, Grady D, Barclay J, Sickles EA, Ernster V
  Effect of age, breast density, and family history on the sensitivity of first screening mammography. JAMA. 1996 Jul 3;276(1):33-8.
•   King V, Brooks JD, Bernstein JL, Reiner AS, Pike MC, Morris EA
  Background parenchymal enhancement at breast MR imaging and breast cancer risk. Radiology. 2011 Jul;260(1):50-60. doi: 10.1148/radiol.11102156. Epub 2011 Apr 14.
•   Kolb TM, Lichy J, Newhouse JH
  Comparison of the performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: an analysis of 27,825 patient evaluations. Radiology. 2002 Oct;225(1):165-75.
•   Kolb TM, Lichy J, Newhouse JH
  Occult cancer in women with dense breasts: detection with screening US--diagnostic yield and tumor characteristics. Radiology. 1998 Apr;207(1):191-9.
•   Kuhl 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.
•   Leconte I, Feger C, Galant C, Berlière M, Berg BV, D'Hoore W, Maldague B
  Mammography and subsequent whole-breast sonography of nonpalpable breast cancers: the importance of radiologic breast density. AJR Am J Roentgenol. 2003 Jun;180(6):1675-9.
•   Mandelson MT, Oestreicher N, Porter PL, White D, Finder CA, Taplin SH, White E
  Breast density as a predictor of mammographic detection: comparison of interval- and screen-detected cancers. J Natl Cancer Inst. 2000 Jul 5;92(13):1081-7.
•   Michaelson JS, Silverstein M, Wyatt J, Weber G, Moore R, Halpern E, Kopans DB, Hughes K
  Predicting the survival of patients with breast carcinoma using tumor size. Cancer. 2002 Aug 15;95(4):713-23.
•   Paci E, Duffy SW, Giorgi D, Zappa M, Crocetti E, Vezzosi V, Bianchi S, del Turco MR
  Quantification of the effect of mammographic screening on fatal breast cancers: The Florence Programme 1990-96. Br J Cancer. 2002 Jul 1;87(1):65-9.
•   Pisano ED, Gatsonis C, Hendrick E, Yaffe M, Baum JK, Acharyya S, Conant EF, Fajardo LL, Bassett L, D'Orsi C, Jong R, Rebner M; Digital Mammographic Imaging Screening Trial (DMIST) Investigators Group
  Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med. 2005 Oct 27;353(17):1773-83. Epub 2005 Sep 16. Erratum in: N Engl J Med. 2006 Oct 26;355(17):1840.
•   Rafferty EA, Park JM, Philpotts LE, Poplack SP, Sumkin JH, Halpern EF, Niklason LT
  Assessing radiologist performance using combined digital mammography and breast tomosynthesis compared with digital mammography alone: results of a multicenter, multireader trial. Radiology. 2013 Jan;266(1):104-13. doi: 10.1148/radiol.12120674. Epub 2012 Nov 20.
•   Ranger B, Littrup PJ, Duric N, Chandiwala-Mody P, Li C, Schmidt S, Lupinacci J
  Breast ultrasound tomography versus MRI for clinical display of anatomy and tumor rendering: preliminary results. AJR Am J Roentgenol. 2012 Jan;198(1):233-9. doi: 10.2214/AJR.11.6910.
•   Rieber A, Brambs HJ, Gabelmann A, Heilmann V, Kreienberg R, Kühn T
  Breast MRI for monitoring response of primary breast cancer to neo-adjuvant chemotherapy. Eur Radiol. 2002 Jul;12(7):1711-9. Epub 2002 Feb 14.
•   Roubidoux MA, Bailey JE, Wray LA, Helvie MA
  Invasive cancers detected after breast cancer screening yielded a negative result: relationship of mammographic density to tumor prognostic factors. Radiology. 2004 Jan;230(1):42-8.
•   Saslow 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. Erratum in: CA Cancer J Clin. 2007 May-Jun;57(3):185.
•   Smith RA, Duffy SW, Gabe R, Tabar L, Yen AM, Chen TH
  The randomized trials of breast cancer screening: what have we learned? Radiol Clin North Am. 2004 Sep;42(5):793-806, v. Review.
•   Sprague BL, Gangnon RE, Burt V, Trentham-Dietz A, Hampton JM, Wellman RD, Kerlikowske K, Miglioretti DL
  Prevalence of mammographically dense breasts in the United States. J Natl Cancer Inst. 2014 Sep 12;106(10). pii: dju255. doi: 10.1093/jnci/dju255. Print 2014 Oct.
•   Stone J, Dite GS, Gunasekara A, English DR, McCredie MR, Giles GG, Cawson JN, Hegele RA, Chiarelli AM, Yaffe MJ, Boyd NF, Hopper JL
  The heritability of mammographically dense and nondense breast tissue. Cancer Epidemiol Biomarkers Prev. 2006 Apr;15(4):612-7.
•   Svahn TM, Chakraborty DP, Ikeda D, Zackrisson S, Do Y, Mattsson S, Andersson I
  Breast tomosynthesis and digital mammography: a comparison of diagnostic accuracy. Br J Radiol. 2012 Nov;85(1019):e1074-82. doi: 10.1259/bjr/53282892. Epub 2012 Jun 6.
•   Swedish Organised Service Screening Evaluation Group
  Effect of mammographic service screening on stage at presentation of breast cancers in Sweden. Cancer. 2007 Jun 1;109(11):2205-12.
•   Swedish Organised Service Screening Evaluation Group
  Reduction in breast cancer mortality from organized service screening with mammography: 1. Further confirmation with extended data. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):45-51.
•   Swedish Organised Service Screening Evaluation Group
  Reduction in breast cancer mortality from the organised service screening with mammography: 2. Validation with alternative analytic methods. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):52-6.
•   Tabár L, Duffy SW, Vitak B, Chen HH, Prevost TC
  The natural history of breast carcinoma: what have we learned from screening? Cancer. 1999 Aug 1;86(3):449-62.
•   Tabar L, Duffy SW, Yen MF, Warwick J, Vitak B, Chen HH, Smith RA
  All-cause mortality among breast cancer patients in a screening trial: support for breast cancer mortality as an end point. J Med Screen. 2002;9(4):159-62.
•   Tabár L, Vitak B, Chen TH, Yen AM, Cohen A, Tot T, Chiu SY, Chen SL, Fann JC, Rosell J, Fohlin H, Smith RA, Duffy SW
  Swedish two-county trial: impact of mammographic screening on breast cancer mortality during 3 decades. Radiology. 2011 Sep;260(3):658-63. doi: 10.1148/radiol.11110469. Epub 2011 Jun 28.
•   Titus-Ernstoff L, Tosteson AN, Kasales C, Weiss J, Goodrich M, Hatch EE, Carney PA
  Breast cancer risk factors in relation to breast density (United States). Cancer Causes Control. 2006 Dec;17(10):1281-90.
•   Torres-Mejía G, De Stavola B, Allen DS, Pérez-Gavilán JJ, Ferreira JM, Fentiman IS, Dos Santos Silva I
  Mammographic features and subsequent risk of breast cancer: a comparison of qualitative and quantitative evaluations in the Guernsey prospective studies. Cancer Epidemiol Biomarkers Prev. 2005 May;14(5):1052-9.
•   Ursin G, Hovanessian-Larsen L, Parisky YR, Pike MC, Wu AH
  Greatly increased occurrence of breast cancers in areas of mammographically dense tissue. Breast Cancer Res. 2005;7(5):R605-8. Epub 2005 Jun 8.
•   Wolfe JN
  Breast patterns as an index of risk for developing breast cancer. AJR Am J Roentgenol. 1976 Jun;126(6):1130-7.

ARM 1: A Prospective, Multicenter, Multi-arm, Clinical Case Collection Program to Acquire Breast Image Data and Establish an Image Library of Exams for Use in Future Research Studies, Training, and Product Development Efforts.

Details for clinical trial NCT03257839