Fallopian Tube CarcinomaNCT02530606
Photoacoustic Imaging in Detecting Ovarian or Fallopian Tube Cancer
A study testing Photoacoustic Imaging in people with Fallopian Tube Carcinoma and Ovarian Carcinoma, run by Stanford University at 1 site in United States.
Trial summary
This pilot clinical trial studies how well photoacoustic imaging works in detecting ovarian or fallopian tube cancer. Photoacoustic imaging is an imaging method that uses lasers to light up tissue, and then converts the light information into ultrasound images. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Fallopian Tube Carcinoma, Ovarian Carcinoma
- What is being tested?
- Photoacoustic Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Nov 2018
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be undergoing ovarian resection
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients who have had primary surgical excision
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
About this study
Official title: Transvaginal Ultrasound and Photoacoustic Imaging of the Ovaries and the Fallopian Tubes: A Clinical Feasibility Study
This pilot clinical trial studies how well photoacoustic imaging works in detecting ovarian or fallopian tube cancer. Photoacoustic imaging is an imaging method that uses lasers to light up tissue, and then converts the light information into ultrasound images. Photoacoustic imaging can provide images of the structure of tissues, as well as their function and the levels of molecules, such as the flow of blood in blood vessels and the level of oxygen in the blood. Photoacoustic imaging may help doctors determine whether a mass is benign (non-cancerous) or cancerous based on the molecular differences between cancer and normal tissue. It may be more accurate and less expensive than other imaging methods, and does not expose patients to radiation.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the performance of photoacoustic imaging (PAI) in detection of ovarian cancer in a clinical setting and to help improve the design of the next generation hand held PAI probe.
SECONDARY OBJECTIVES:
- To evaluate vasculature and oxygen saturation in lesions based on PAI-measurements.
OUTLINE:
Patients undergo PAI over 15-30 minutes prior to the ovarian excision.
- Conditions
- Fallopian Tube Carcinoma, Ovarian Carcinoma
- Being tested
- Photoacoustic Imaging
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoacoustic ImagingProcedure or surgery
Undergo PAI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (PAI) | Experimental | Patients undergo PAI over 15-30 minutes prior to the ovarian excision. Receives: Procedure: Photoacoustic Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of lesion from skin surface as measured by ultrasound (US)
Descriptive statistics (proportions, means) will be used to summarize depth of lesion. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Measured: Baseline (at the time of surgery)
Lesion total hemoglobin per PAI
Descriptive statistics (proportions, means) will be used to summarize lesion total hemoglobin. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Measured: Post-surgery processing (up to 1 year)
PAI signal intensity measured as signal-to-noise ratio (SNR) in dB in region of interest (ROI)
Descriptive statistics (proportions, means) will be used to summarize PAI signal intensity. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Measured: Post-surgery processing (up to 1 year)
Percent SO2 in ROI
Descriptive statistics (proportions, means) will be used to summarize percent SO2 in ROI. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Measured: Post-surgery processing (up to 1 year)
Size of lesion as measured by US
Descriptive statistics (proportions, means) will be used to summarize size of lesion. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Measured: Baseline (at the time of surgery)
Time span for PAI examination
Descriptive statistics (proportions, means) will be used to summarize time span for PAI examination. The distribution of signal intensity on PAI, total hemoglobin concentration (HbT), and oxygen saturation (SO2) will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the receiver operating characteristic (ROC) curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Measured: Baseline (at the time of surgery)
Visibility/quality rating of PAI-image as measured by 5-level scale: not visible, barely visible, fair (or moderately) visible, visible, and clearly visible
Descriptive statistics (proportions, means) will be used to summarize visibility/quality rating of PAI. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Measured: Baseline (at the time of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionNov 2018
Why it stopped: Efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CarcinomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjiv Gambhir, Principal investigator, Stanford Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530606
- Sponsor's protocol ID
- GYNOPF0014
- Other IDs
- NCI-2015-01284, 348, 31295
- Status last verified
- Nov 2018
- First submitted
- 19 Aug 2015
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Ultrasound and Photoacoustic Imaging of the Ovaries and the Fallopian Tubes: A Clinical Feasibility Study
- ClinicalTrials.gov ID
- NCT02530606
- Acronym / sponsor ID
- GYNOPF0014
- Conditions
- Fallopian Tube Carcinoma, Ovarian Carcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Efficacy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Nov 2018 (actual)
- First posted
- 21 Aug 2015 (estimated)
- 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.
This pilot clinical trial studies how well photoacoustic imaging works in detecting ovarian or fallopian tube cancer. Photoacoustic imaging is an imaging method that uses lasers to light up tissue, and then converts the light information into ultrasound images. Photoacoustic imaging can provide images of the structure of tissues, as well as their function and the levels of molecules, such as the flow of blood in blood vessels and the level of oxygen in the blood. Photoacoustic imaging may help doctors determine whether a mass is benign (non-cancerous) or cancerous based on the molecular differences between cancer and normal tissue. It may be more accurate and less expensive than other imaging methods, and does not expose patients to radiation.
Detailed description
PRIMARY OBJECTIVES:
- To assess the performance of photoacoustic imaging (PAI) in detection of ovarian cancer in a clinical setting and to help improve the design of the next generation hand held PAI probe.
SECONDARY OBJECTIVES:
- To evaluate vasculature and oxygen saturation in lesions based on PAI-measurements.
OUTLINE:
Patients undergo PAI over 15-30 minutes prior to the ovarian excision.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (PAI) | Experimental | Procedure: Photoacoustic ImagingPatients undergo PAI over 15-30 minutes prior to the ovarian excision. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must be undergoing ovarian resection
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (2 listed)
- Patients who have had primary surgical excision
- Pregnant or lactating women
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 |
|---|---|---|
| Photoacoustic ImagingUndergo PAI | Procedure or surgery | Diagnostic (PAI) |
Primary outcome
Depth of lesion from skin surface as measured by ultrasound (US)
Time frame: Baseline (at the time of surgery)
Descriptive statistics (proportions, means) will be used to summarize depth of lesion. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Lesion total hemoglobin per PAI
Time frame: Post-surgery processing (up to 1 year)
Descriptive statistics (proportions, means) will be used to summarize lesion total hemoglobin. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
PAI signal intensity measured as signal-to-noise ratio (SNR) in dB in region of interest (ROI)
Time frame: Post-surgery processing (up to 1 year)
Descriptive statistics (proportions, means) will be used to summarize PAI signal intensity. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Percent SO2 in ROI
Time frame: Post-surgery processing (up to 1 year)
Descriptive statistics (proportions, means) will be used to summarize percent SO2 in ROI. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Size of lesion as measured by US
Time frame: Baseline (at the time of surgery)
Descriptive statistics (proportions, means) will be used to summarize size of lesion. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Time span for PAI examination
Time frame: Baseline (at the time of surgery)
Descriptive statistics (proportions, means) will be used to summarize time span for PAI examination. The distribution of signal intensity on PAI, total hemoglobin concentration (HbT), and oxygen saturation (SO2) will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the receiver operating characteristic (ROC) curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Visibility/quality rating of PAI-image as measured by 5-level scale: not visible, barely visible, fair (or moderately) visible, visible, and clearly visible
Time frame: Baseline (at the time of surgery)
Descriptive statistics (proportions, means) will be used to summarize visibility/quality rating of PAI. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
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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.
Sanjiv Gambhir principal investigator
Stanford Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photoacoustic Imaging in people with Fallopian Tube Carcinoma and Ovarian Carcinoma, run by Stanford University 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 2 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: withdrawn, as of the sponsor's last update on 28 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Depth of lesion from skin surface as measured by ultrasound (US) (time frame: Baseline (at the time of surgery)). The study lists 7 primary outcomes in all. 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 28 Nov 2018.