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NCT02115607 · ClinicalTrials.gov registry record · NA

Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

Completed
Registry status
NA
Development phase
17
Enrollment target

NCT02115607: Completed NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

NCT02115607 is a NA study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02115607, a NA study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

COMPLETED
Registry status
NA
Development phase
17 participants
Enrollment target

Study Summary

This is a diagnostic accuracy study to evaluate if two novel ultrasound (US) techniques, quantitative 3D subharmonic imaging (SHI) and Subharmonic Aided Pressure Estimation (SHAPE), used with an intravenous ultrasound contrast agent (Definity, Lantheus Medical Imaging, Billerica, MA), can track changes in locally advanced breast cancer (LABC) angiogenesis and interstitial fluid pressure (IFP), respectively, by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 60% (in part 1) or 30% (in part 2) of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment. Results will be compared to MRI and pathology.

Primary Outcome

To evaluate the ability of SHAPE, used with Definity, to track changes in interstitial fluid pressure (IFP) by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 30% of the neoadjuvant chemotherapy treatment delivered and comparing results to MRI and pathology.

Interventions

  • DRUG Definity infusion

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2014-03
Est. Completion 2018-05-23
Phase NA

What the finished NCT02115607 record still lists

NCT02115607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Definity infusion is the first listed.

NCT02115607 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02115607 about?

NCT02115607 is a clinical study titled "Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy". This is a diagnostic accuracy study to evaluate if two novel ultrasound (US) techniques, quantitative 3D subharmonic imaging (SHI) and Subharmonic Aided Pressure Estimation (SHAPE), used with an intravenous ultrasound contrast agent (Definity, Lantheus Medical Imaging, Billerica, MA), can track chan...

What is the current status of trial NCT02115607?

This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2014-03. Estimated completion is 2018-05-23.

What interventions are being tested in trial NCT02115607?

The interventions under investigation include: Definity infusion (DRUG).

Who is sponsoring clinical trial NCT02115607?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02115607's enrollment target sits among peer trials

17 1871st of 2000 higher than 130 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT02115607, the US trial registry maintained by the National Library of Medicine. NCT02115607 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.