OophorectomyPhase 1NCT03262818
Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
A Phase 1 study testing Transvaginal ultrasound and Ultrasound/Photoacoustic imaging in people with Oophorectomy, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators have developed co-registered photoacoustic and ultrasound (US) imaging technique that allows the investigators to visualize tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development that is not available by US alone. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Oophorectomy
- What is being tested?
- Transvaginal ultrasound and Ultrasound/Photoacoustic imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 20 Nov 2018
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Referred to Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy
- Willingness to participate in the study
- Able to provide informed consent
Who cannot join
- Younger than 18 years of age
- Not able to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The investigators have developed co-registered photoacoustic and ultrasound (US) imaging technique that allows the investigators to visualize tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes in the ovary, using a non-invasive imaging modality will greatly enhance the care for women.
- Conditions
- Oophorectomy
- Being tested
- Transvaginal ultrasound, Ultrasound/Photoacoustic imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasoundDevice
Also called Transvaginal US
-Will be performed by US technologists at Washington University School of Medicine and read by Dr. Cary Siegel or Dr. Kathryn Robinson
Ultrasound/Photoacoustic imagingDevice
Also called US/PAI
-The light illumination for the photoacoustic imaging system is provided by a wavelength-tunable Ti:Sapphire laser (LOTIS TII), optically pumped by an Nd:YAG laser (LOTIS TII) at 532 nm wavelength.
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging | Experimental | * Transvaginal ultrasound (US) prior to surgery
* Immediately after the transvaginal US, US/PAI imaging will be performed
* Once the surgeon has removed the ovary(ies) they will be imaged ex vivo. The in vivo and ex vivo US/PAI images will be compared with the final pathologic diagnosis Receives: Device: Transvaginal ultrasound; Device: Ultrasound/Photoacoustic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure PAI/ultrasound signatures from ovaries prior to surgery
-The transvaginal US will be performed by US technologists or radiologists at the Radiology Department and images will be read by one of the study radiologists either Dr. Cary Siegel or Dr. Kathryn Robinson of the Radiology Department. The reading will be categorized as normal, suspicious or highly suspicious. The scores will serve as a baseline comparison of US/PAI technique with the current clinical practice using US. Immediately after the transvaginal US, US/PAI imaging will be performed with the assistance of the US technologist or radiologist.
Measured: Prior to surgery (no more than 30 days prior to surgery)
Secondary outcomes (2)
Characterize the tissue images with pathologic diagnosis
-The in vivo and ex vivo PAI/US images with be compared with final pathologic diagnosis.
Measured: At the time of surgery (no more than 30 days after PAI/US)
Refine the system and imaging algorithms based on the characteristic features of in vivo imaging
-Will be used to distinguish between benign and malignant ovarian tissues. Student t-test will be used for statistical significant test of each feature obtained from malignant and benign ovaries. Those features with p value less than 0.05 will be used as a predictor.
Measured: At the time of surgery (no more than 30 days after PAI/US)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Feb 2017
- Primary completion19 Nov 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OophorectomyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Cary L Siegel, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262818
- Sponsor's protocol ID
- 201608016
- Other IDs
- 5R01CA151570-02
- Status last verified
- Nov 2018
- First submitted
- 23 Aug 2017
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
- ClinicalTrials.gov ID
- NCT03262818
- Acronym / sponsor ID
- 201608016
- Conditions
- Oophorectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 25 Aug 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.
The investigators have developed co-registered photoacoustic and ultrasound (US) imaging technique that allows the investigators to visualize tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes in the ovary, using a non-invasive imaging modality will greatly enhance the care for women.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging | Experimental | Device: Transvaginal ultrasound, Device: Ultrasound/Photoacoustic imaging* Transvaginal ultrasound (US) prior to surgery * Immediately after the transvaginal US, US/PAI imaging will be performed * Once the surgeon has removed the ovary(ies) they will be imaged ex vivo. The in vivo and ex vivo US/PAI images will be compared with the final pathologic diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Referred to Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy
- Willingness to participate in the study
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Younger than 18 years of age
- Not able to provide informed consent
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 |
|---|---|---|
| Transvaginal ultrasoundAlso: Transvaginal US-Will be performed by US technologists at Washington University School of Medicine and read by Dr. Cary Siegel or Dr. Kathryn Robinson | Device | Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging |
| Ultrasound/Photoacoustic imagingAlso: US/PAI-The light illumination for the photoacoustic imaging system is provided by a wavelength-tunable Ti:Sapphire laser (LOTIS TII), optically pumped by an Nd:YAG laser (LOTIS TII) at 532 nm wavelength. | Device | Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging |
Primary outcome
Measure PAI/ultrasound signatures from ovaries prior to surgery
Time frame: Prior to surgery (no more than 30 days prior to surgery)
-The transvaginal US will be performed by US technologists or radiologists at the Radiology Department and images will be read by one of the study radiologists either Dr. Cary Siegel or Dr. Kathryn Robinson of the Radiology Department. The reading will be categorized as normal, suspicious or highly suspicious. The scores will serve as a baseline comparison of US/PAI technique with the current clinical practice using US. Immediately after the transvaginal US, US/PAI imaging will be performed with the assistance of the US technologist or radiologist.
2 secondary outcomes
Characterize the tissue images with pathologic diagnosis
Time frame: At the time of surgery (no more than 30 days after PAI/US)
Refine the system and imaging algorithms based on the characteristic features of in vivo imaging
Time frame: At the time of surgery (no more than 30 days after PAI/US)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Cary L Siegel, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transvaginal ultrasound and Ultrasound/Photoacoustic imaging in people with Oophorectomy, run by Washington University School of Medicine 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 23 Nov 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure PAI/ultrasound signatures from ovaries prior to surgery (time frame: Prior to surgery (no more than 30 days prior to surgery)). 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 23 Nov 2018.