Esophageal CancerNCT03211780
Use of Intra-Operative Shear Wave Ultrasound Vibrometry for Characterization of Esophageal Malignant Tumors
A study testing General Electric LOGIQ E9 ultrasound system in people with Esophageal Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
Using the analysis of group velocity for a screening application and then higher order analysis based on the elastic and viscious components of the shear modulus may allow discrimination between extent of tumor invasion through the esophageal wall if appropriately correlated with pathological findings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- General Electric LOGIQ E9 ultrasound system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2017to 24 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Scheduled to undergo esophageal reconstruction for presumed or known esophageal cancer
- Subject is able to understand the study procedures and provide informed consent.
Who cannot join
- Subject is pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Using the analysis of group velocity for a screening application and then higher order analysis based on the elastic and viscious components of the shear modulus may allow discrimination between extent of tumor invasion through the esophageal wall if appropriately correlated with pathological findings.
Read the detailed description
Use of ultrasound-based vibrometry in this setting would allow for a relatively simple study and translation of clinical practice, as the same devices are already used in this setting, and operators have familiarity with the equipment. Incorporating another additional method to generate contrast for determining malignant tissue from normal based on biomechanical properties with the same probe would have benefit as an additional diagnostic modality.
- Conditions
- Esophageal Cancer
- Being tested
- General Electric LOGIQ E9 ultrasound system
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Electric LOGIQ E9 ultrasound systemDevice
Patients will be brought to the operating room in line with standard clinical practice and after esophageal exposure, but before surgical mobilization of the esophagus, shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Not described Receives: Device: General Electric LOGIQ E9 ultrasound system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining malignant esophageal tissue from normal tissue
Determining malignant esophageal tissue from normal tissue by measurements using the General Electric LOGIQ E9 ultrasound system.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start20 Sep 2017
- Primary completion24 Apr 2019
- Study completion24 Apr 2019
Why it stopped: Terminated due to the inability to enroll and carry out study intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Wigle, Mayo Clinic
- Investigators
- Dennis Wigle, MD, PhD, Principal investigator, Mayo ClinicMatthew Urban, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211780
- Sponsor's protocol ID
- 17-002253
- Status last verified
- Oct 2019
- First submitted
- 3 Jul 2017
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intra-Operative Shear Wave Ultrasound Vibrometry for Characterization of Esophageal Malignant Tumors
- ClinicalTrials.gov ID
- NCT03211780
- Acronym / sponsor ID
- 17-002253
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to the inability to enroll and carry out study intervention.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using the analysis of group velocity for a screening application and then higher order analysis based on the elastic and viscious components of the shear modulus may allow discrimination between extent of tumor invasion through the esophageal wall if appropriately correlated with pathological findings.
Detailed description
Use of ultrasound-based vibrometry in this setting would allow for a relatively simple study and translation of clinical practice, as the same devices are already used in this setting, and operators have familiarity with the equipment. Incorporating another additional method to generate contrast for determining malignant tissue from normal based on biomechanical properties with the same probe would have benefit as an additional diagnostic modality.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Device: General Electric LOGIQ E9 ultrasound system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Scheduled to undergo esophageal reconstruction for presumed or known esophageal cancer
- Subject is able to understand the study procedures and provide informed consent.
Key exclusion criteria (1 listed)
- Subject is pregnant or breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General Electric LOGIQ E9 ultrasound systemPatients will be brought to the operating room in line with standard clinical practice and after esophageal exposure, but before surgical mobilization of the esophagus, shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively. | Device | Ultrasound |
Primary outcome
Determining malignant esophageal tissue from normal tissue
Time frame: 1 week
Determining malignant esophageal tissue from normal tissue by measurements using the General Electric LOGIQ E9 ultrasound system.
Results and safety
The study was stopped early (reason given: Terminated due to the inability to enroll and carry out study intervention.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Wigle, MD, PhD principal investigator
Mayo Clinic
Matthew Urban, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Electric LOGIQ E9 ultrasound system in people with Esophageal Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated due to the inability to enroll and carry out study intervention.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining malignant esophageal tissue from normal tissue (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.