Trial · NCT01490892
Quantitative Subharmonic Breast Imaging
NCT01490892, Phase 4, Completed, Thomas Jefferson University; results first posted 2020-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Quantitative Subharmonic Breast Imaging. Trials, record NCT01490892. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01490892
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Quantitative Subharmonic Breast Imaging
- NCT number
- NCT01490892
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 219 participants, actual
- Lead sponsor
- Thomas Jefferson University
- Conditions
- Breast Cancer
- Interventions
- 3D HI and SHI of UCA
- First posted
- 2011-12-13
- Last updated
- 2025-05-06
- Results first posted
- 2020-01-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 2 hours | Characterization of benign and malignant breast cancer lesions is compared by each imaging method which evaluates vascular activity. Imaging methods to be compared are 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI), fundamental grayscale ultrasound (US) or power Doppler imaging (PDI). Data will be analyzed qualitatively. |
| Secondary | Change in Vascular Volume of Breast Lesions as Assessed by Subharmonic Imaging (SHI) Signal Intensity | 2 hours | Quantitative measures of the vascular volumes of breast lesions determined by SHI utilizing bifurcations and vessel length, and blood pool and parametric imaging |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 2 hours | lesions | NUMBER | |
| SECONDARY | Change in Vascular Volume of Breast Lesions as Assessed by Subharmonic Imaging (SHI) Signal Intensity | 2 hours | breast cancer lesions | dB | MEAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 3D HI and SHI of UCA | Power Doppler Imaging (PDI) : Benign | 69 | lesions | |
| Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 3D HI and SHI of UCA | Power Doppler Imaging (PDI) : Malignant | 24 | lesions | |
| Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 3D HI and SHI of UCA | Power Doppler Imaging (PDI) : Not Characterized | 126 | lesions | |
| Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 3D HI and SHI of UCA | 3D SHI : Benign | 58 | lesions | |
| Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 3D HI and SHI of UCA | 3D SHI : Malignant | 25 | lesions | |
| Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 3D HI and SHI of UCA | 3D SHI : Not Characterized | 136 | lesions | |
| Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 3D HI and SHI of UCA | Harmonic Imaging (HI) : Benign | 3 | lesions | |
| Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 3D HI and SHI of UCA | Harmonic Imaging (HI) : Malignant | 5 | lesions | |
| Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 3D HI and SHI of UCA | Harmonic Imaging (HI) : Not Characterized | 211 | lesions | |
| Change in Vascular Volume of Breast Lesions as Assessed by Subharmonic Imaging (SHI) Signal Intensity | 3D HI and SHI of UCA | Central Benign lesions | 1.83 | Standard Deviation 0.16 | dB |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 3D HI and SHI of UCA | 219 | |
| Overall Study | COMPLETED | 3D HI and SHI of UCA | 219 | |
| Overall Study | NOT COMPLETED | 3D HI and SHI of UCA | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 3D HI and SHI of UCA | 2 | 219 |
| Total, other adverse events | 3D HI and SHI of UCA | 0 | 219 |
| Total, serious adverse events | 3D HI and SHI of UCA | 0 | 219 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 17690324 | BACKGROUND |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA140338 | Quantitative Subharmonic Breast Imaging | FORSBERG, FLEMMING | THOMAS JEFFERSON UNIVERSITY | NATIONAL CANCER INSTITUTE | 2010 to 2014 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01490892
GET https://conductscience.org/api/trials/v1/NCT01490892/registered