Clinical trial · Interventional
An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall
NCT00208871CI-TRIAL-00012689completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary goal of this study is to compare, within a clinical screening setting, the performance of stereoscopic digital mammography with standard (non-stereo) digital mammography in the detection of abnormalities in the breast, including early breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereoscopic Digital Mammography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- sensitivity/specificity
- timeFrame
- Aug '04 to Dec '07
Secondary outcomes (1)
- measure
- Recall rate
- timeFrame
- Aug '04 to December '7
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Personal risk factors (any of the following) * Personal history of breast and/or ovarian cancer, regardless of age. * Prior breast biopsy that included any of the following high risk, benign lesion: Lobular carcinoma in-situ, Atypical ductal hyperplasia, Atypical lobular hyperplasia, Atypical columnar hyperplasia. * Positive test for known mutations of BRCA 1 or 2 genes, regardless of age. * History of chest irradiation for treatment of non-breast disease (EX:lymphoma, lung cancer) at least 15 years prior to enrollment. Family history (over 30 years of age with any of the following, some exceptions may appy) * Ashkenazi Jewish ancestry, regardless of age. * Any history of male breast cancer on the maternal or paternal side. * Breast and ovarian cancer in a close relative (mother, sister, daughter) * Breast or ovarian cancer in more than one close relative (mother,sister daughter) * Breast cancer in a close relative (mother, sister, daughter) with early onset(\<50 years of age) * Breast and ovarian cancer in a 2nd. degree relative (grandmother, aunt, niece) with early onset of breast cancer. (\<50 years of age) * Multiple history of breast cancer in 1st. and 2nd. degree relatives. Exclusion Criteria: * Patient does not meet any of the inclusion criteria, * Patient has had breast augmentation, except for unilateral augmentation done for prior mastectomy, * Patient has suspected or confirmed pregnancy, * Patient has large breasts that cannot be adequately imaged on the 19 x 23 cm detector surface of the GE Senographe 2000D digital mammography unit.
References
Publications (4)
- BACKGROUNDGetty DJ, Pickett RM, D'Orsi CJ. Stereoscopic digital mammography: improving detection and diagnosis of breast cancer. In: Computer Assisted Radiology and Surgery (CARS-2001). Berlin, Germany: Elsevier Science B.V., 2001.
- BACKGROUNDGetty D. J. Stereoscopic digital mammography. Proceedings of the First Americas Display Engineering and Applications Conference (ADEAC '04), Ft. Worth, 2004, 11-14.
- BACKGROUNDGetty, D. J. Stereoscopic and biplane digital radiography. In E. Samei & M. Flynn (Eds.), RSNA Categorical Course in Diagnostic Radiology Physics: Advances in Digital Radiography. RSNA Publications, 2003; 199-209.
- RESULTGetty, D. J. Stereoscopic digital mammography: perceptual and display factors leading to improved early detection of breast cancer. In H-O Peitgen (Ed.), Digital Mammography, IWDM 2002, 6th International Workshop on Digital Mammography. Berlin: Springer, 2003, 431-435.