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Trial · NCT02967458

Detection of High Grade Prostate Cancer With Subharmonic Ultrasound Imaging, A Pilot Study

NCT02967458, Phase 2, Completed, Thomas Jefferson University; results first posted 2019-05-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Detection of High Grade Prostate Cancer With Subharmonic Ultrasound Imaging, A Pilot Study. Trials, record NCT02967458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02967458

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Detection of High Grade Prostate Cancer With Subharmonic Ultrasound Imaging, A Pilot Study
NCT number
NCT02967458
Status
Completed
Phases
Phase 2
Enrollment
55 participants, actual
Lead sponsor
Thomas Jefferson University
Conditions
Prostatic Neoplasm
Interventions
Perflutren Lipid Microsphere Intravenous Suspension
First posted
2016-11-18
Last updated
2025-04-30
Results first posted
2019-05-21

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPercentage of Subjects Whose Prostate Cancer Was Detected With Subharmonic ImagingOne week from baseline
The initial phase of the trial will develop and test subharmonic imaging to demonstrate enhanced visualization of prostate vascularity in all study participants. We will report the percentage of study subjects in whom visualization of prostate vascularity is increased with subharmonic imaging.
PrimaryPercentage of Biopsy Cores in Which Prostate Cancer Was Detected Using Subharmonic ImagingOne week from baselineStudy subjects will be scanned with subharmonic imaging during infusion of the microbubble contrast agent. Imaging results will be compared to pathology on prostate biopsy.
PrimaryPercentage of Subjects With Previously Unidentified Prostate Cancer Using Magnetic Resonance ImagingOne week from baselineStudy subjects will be scanned with subharmonic imaging during infusion of the microbubble contrast agent. Imaging results will be compared to pathology on prostate biopsy.

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage of Subjects Whose Prostate Cancer Was Detected With Subharmonic ImagingOne week from baselineParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPercentage of Biopsy Cores in Which Prostate Cancer Was Detected Using Subharmonic ImagingOne week from baselinepercentage of biopsy coresNUMBER
PRIMARYPercentage of Subjects With Previously Unidentified Prostate Cancer Using Magnetic Resonance ImagingOne week from baselineThirty one subjects of the total 55 had prior negative MRI or negative MRI guided biopsyParticipantsCOUNT_OF_PARTICIPANTS

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Percentage of Subjects Whose Prostate Cancer Was Detected With Subharmonic Imaging1Prostate Biopsy Patients24Participants
Percentage of Biopsy Cores in Which Prostate Cancer Was Detected Using Subharmonic ImagingProstate Biopsy Patients8.33percentage of biopsy cores
Percentage of Subjects With Previously Unidentified Prostate Cancer Using Magnetic Resonance ImagingProstate Biopsy Patients9Participants

Participant flow3

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDProstate Biopsy Patients55
Overall StudyCOMPLETEDProstate Biopsy Patients55
Overall StudyNOT COMPLETEDProstate Biopsy Patients0

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherHivesSkin and subcutaneous tissue disordersProstate Biopsy Patients1551
otherThroat TightnessGeneral disordersProstate Biopsy Patients1551

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityProstate Biopsy Patients055
Total, other adverse eventsProstate Biopsy Patients255
Total, serious adverse eventsProstate Biopsy Patients055

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
16240450BACKGROUNDPubMed
17936814BACKGROUNDPubMed
18158034BACKGROUNDPubMed
20719368BACKGROUNDPubMed
22179312BACKGROUNDPubMed
22998915BACKGROUNDPubMed

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R21CA202214Detection of High Grade Prostate Cancer with Subharmonic Ultrasound ImagingHALPERN, ETHAN J; FORSBERG, FLEMMINGTHOMAS JEFFERSON UNIVERSITYNATIONAL CANCER INSTITUTE2016 to 2017

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT02967458

GET https://conductscience.org/api/trials/v1/NCT02967458/registered