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NCT03297112 · ClinicalTrials.gov registry record · Early Phase 1
Contrast-Enhanced Subharmonic Ultrasound Imaging in Improving Characterization of Adnexal Masses in Patients Undergoing Surgery
A Early Phase 1 study of Adnexal Mass, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03297112: Completed Early Phase 1 study of Adnexal Mass, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT03297112 is a Early Phase 1 study of Adnexal Mass that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03297112, a Early Phase 1 study of Adnexal Mass, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot clinical trial studies how well contrast-enhanced subharmonic ultrasound imaging works in improving the characterization of adnexal masses in patients undergoing surgery. Contrast-enhanced subharmonic ultrasound imaging uses high-frequency sound waves to produce images of internal organs and when combined with an ultrasound agent such as perflutren lipid microspheres, may help improve imaging and management of adnexal masses.
Primary Outcome
The techniques will be compared using an analysis of variance (ANOVA) method (i.e., baseline ultrasound imaging, SHI, or MRI) as the dependent variable and outcome as the independent variables. Diagnostic accuracy of lesion identification as "no lesion seen", "definitely benign", "indeterminate" or "definitely malignant" based on independent reads by experience radiologists for SHI with and without contrast vs contrast-enhanced MRI (quantitative analysis). For qualitative analysis, digital image
Conditions Studied
Interventions
- DRUG Perflutren Lipid Microspheres
- PROCEDURE Contrast-Enhanced Subharmonic Ultrasound Imaging
Study Locations (1)
Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2018-09-04 |
| Phase | Early Phase 1 |
What the finished NCT03297112 record still lists
NCT03297112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Adnexal Mass appearing as the primary indexed condition, and to 2 interventions - of which Perflutren Lipid Microspheres is the first listed.
NCT03297112 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03297112 about?
NCT03297112 is a clinical study titled "Contrast-Enhanced Subharmonic Ultrasound Imaging in Improving Characterization of Adnexal Masses in Patients Undergoing Surgery". This pilot clinical trial studies how well contrast-enhanced subharmonic ultrasound imaging works in improving the characterization of adnexal masses in patients undergoing surgery. Contrast-enhanced subharmonic ultrasound imaging uses high-frequency sound waves to produce images of internal organs ...
What is the current status of trial NCT03297112?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2017-08-01. Estimated completion is 2018-09-04.
What conditions does trial NCT03297112 study?
This clinical trial studies the following conditions: Adnexal Mass.
What interventions are being tested in trial NCT03297112?
The interventions under investigation include: Perflutren Lipid Microspheres (DRUG), Contrast-Enhanced Subharmonic Ultrasound Imaging (PROCEDURE).
Who is sponsoring clinical trial NCT03297112?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03297112 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03297112's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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