Cervical CancerNCT03318107
Ultrasound and Photoacoustic Imaging for Cervical Cancer
A study testing Transvaginal probe using photoacoustic and ultrasound imaging in people with Cervical Cancer and Cancer of the Cervix, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators have developed co-registered transvaginal photoacoustic and ultrasound (US) imaging techniques that allow them to visualize ovarian tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development or residual tumors after systemic treatment that… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cancer of the Cervix
- What is being tested?
- Transvaginal probe using photoacoustic and ultrasound imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2018to 9 Aug 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
- Women only
- No healthy volunteers
- Adult, Older adult
- Diagnosis of cervical cancer of any stage that will be treated with radiation therapy and concurrent chemotherapy.
- At least 18 years of age.
- Not pregnant and/or breastfeeding.
- Able to understand and willing to sign an IRB-approved written informed consent document.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Pilot Study of Ultrasound and Photoacoustic Imaging for Assessing Treatment Response of Cervical Cancer Patients
The investigators have developed co-registered transvaginal photoacoustic and ultrasound (US) imaging techniques that allow them to visualize ovarian tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development or residual tumors after systemic treatment that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes using a non-invasive imaging modality will greatly enhance the care for patients. The investigators plan to explore these techniques in monitoring cervical cancer treatment response and conduct pilot feasibility studies.
- Conditions
- Cervical Cancer, Cancer of the Cervix
- Being tested
- Transvaginal probe using photoacoustic and ultrasound imaging
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal probe using photoacoustic and ultrasound imagingDevice
-Four optical wavelengths of 730nm, 780nm, 800 nm, and 830 nm will be used to acquire data
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal probe (Photoacoustic + ultrasound imaging) | Experimental | * A transvaginal imaging probe using ultrasound and photoacoustic imaging will be inserted into the vagina and will use different frequencies of lights to create images
* This will occur before the first standard of care treatment, mid-treatment, end of treatment, and approximately 3 months after the end of treatment for a total of 4 imaging time points Receives: Device: Transvaginal probe using photoacoustic and ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete the imaging protocol
Measured: Approximately 18 weeks
Secondary outcomes (2)
Reduction rate of tumor angiogenesis
- The reduction rate of tumor angiogenesis of clinical responders and non-responders will be analyzed
- Responders and non-responders will be determined by standard of care PET imaging based on F18-FDG uptake, 3 months after completion of treatment
Measured: 3 months after completion of standard of care treatment (approximately 18 weeks)
Charge pattern of blood oxygen saturation
- The charge pattern of blood oxygen saturation of clinical responders and non-responders will be analyzed
- Responders and non-responders will be determined by standard of care PET imaging based on F18-FDG uptake, 3 months after completion of treatment
Measured: 3 months after completion of standard of care treatment (approximately 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start15 Feb 2018
- Primary completion9 Aug 2019
- Study completion9 Aug 2019
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perry W Grigsby, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318107
- Sponsor's protocol ID
- 201710024
- Status last verified
- May 2020
- First submitted
- 17 Oct 2017
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Ultrasound and Photoacoustic Imaging for Assessing Treatment Response of Cervical Cancer Patients
- ClinicalTrials.gov ID
- NCT03318107
- Acronym / sponsor ID
- 201710024
- Conditions
- Cervical Cancer, Cancer of the Cervix
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 23 Oct 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 transvaginal photoacoustic and ultrasound (US) imaging techniques that allow them to visualize ovarian tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development or residual tumors after systemic treatment that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes using a non-invasive imaging modality will greatly enhance the care for patients. The investigators plan to explore these techniques in monitoring cervical cancer treatment response and conduct pilot feasibility studies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transvaginal probe (Photoacoustic + ultrasound imaging) | Experimental | Device: Transvaginal probe using photoacoustic and ultrasound imaging* A transvaginal imaging probe using ultrasound and photoacoustic imaging will be inserted into the vagina and will use different frequencies of lights to create images * This will occur before the first standard of care treatment, mid-treatment, end of treatment, and approximately 3 months after the end of treatment for a total of 4 imaging time points |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 probe using photoacoustic and ultrasound imaging-Four optical wavelengths of 730nm, 780nm, 800 nm, and 830 nm will be used to acquire data | Device | Transvaginal probe (Photoacoustic + ultrasound imaging) |
Primary outcome
Number of participants who complete the imaging protocol
Time frame: Approximately 18 weeks
2 secondary outcomes
Reduction rate of tumor angiogenesis
Time frame: 3 months after completion of standard of care treatment (approximately 18 weeks)
Charge pattern of blood oxygen saturation
Time frame: 3 months after completion of standard of care treatment (approximately 18 weeks)
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- 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.
Perry W Grigsby, 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 study testing Transvaginal probe using photoacoustic and ultrasound imaging in people with Cervical Cancer and Cancer of the Cervix, 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?
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 29 May 2020. 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: Low accrual). 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?
Number of participants who complete the imaging protocol (time frame: Approximately 18 weeks). 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 29 May 2020.