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Ultrasound + Photoacoustic Imaging for Ovarian Health
N/A
Recruiting
Led By Cary L Siegel, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented deleterious mutation in one of the following ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, PMS2, or EPCAM.
All patients, 18 years or older, referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 4.5 years)
Awards & highlights
Study Summary
This trial is testing if a new imaging technique can reduce unnecessary surgeries without missing cancer. It's also testing if the technique can help find early ovarian cancer in high risk patients.
Who is the study for?
This trial is for adults who may carry certain genetic mutations linked to ovarian cancer (like BRCA1/2) and are referred for surgery that includes removal of at least one ovary. Participants should be willing to be monitored for 1-2 years before deciding on preventive ovary removal.Check my eligibility
What is being tested?
The study tests if photoacoustic imaging, combined with ultrasound, can reduce unnecessary surgeries while still effectively detecting ovarian cancer, especially in early stages among high-risk patients.See study design
What are the potential side effects?
Since the interventions involve non-invasive imaging techniques like photoacoustic imaging and ultrasound, there are typically no significant side effects associated with these procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ovarian cancer has a harmful mutation in a specific gene.
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I am 18 or older and need surgery that includes removing one ovary.
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I am referred to Washington University for surgery that includes removing one ovary.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 4.5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 4.5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess the impact of co-registered PAI/US on the potential reduction of benign surgeries as measured by the area under receiver characteristic curve (AUC)
Secondary outcome measures
Malignant Neoplasms
Other outcome measures
Determine if co-registered PAI/US can be used as a sensitive and specific screening tool for early detection of malignant neoangiogenesis within a group of high-risk women
Determine normal changes of photoacoustic imaging parameters
Trial Design
1Treatment groups
Experimental Treatment
Group I: Transvaginal photoacoustic imaging/ultrasoundExperimental Treatment2 Interventions
Baseline transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging for all participants enrolled
Once the surgeon has surgically removed the ovary(ies), they will be imaged with the photoacoustic imaging/ultrasound
For the exploratory outcome measure for high risk participants (approximately 50 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally at 6 months, 12 months, 18 months, 24 months, and at the time of surgery
For the exploratory outcome measure for high risk participants (approximately 10 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally every 2 weeks at follicular phase and at the luteal phase for 3 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound
2013
Completed Phase 1
~1950
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,763 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,496 Total Patients Enrolled
Cary L Siegel, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My ovarian cancer has a harmful mutation in a specific gene.I am willing to be monitored for 1-2 years before deciding on preventive ovary removal.I am willing and able to give my consent to participate in the study.I meet the requirements for the study's main and additional health outcome measures.I am 18 or older and need surgery that includes removing one ovary.I am referred to Washington University for surgery that includes removing one ovary.Requirements to be included in the study's additional analysis.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Transvaginal photoacoustic imaging/ultrasound
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the numerical representation of participants in this scientific study?
"Affirmative. According to clinicaltrials.gov, this experiment is presently searching for participants; the trial was initially published on February 9th 2020 and has been amended most recently on September 8th 2022. 230 individuals are needed from a single site."
Answered by AI
Is this trial actively seeking out participants?
"According to the details archived on clinicaltrials.gov, this medical experiment is presently enrolling volunteers and has been ongoing since February 9th 2020 with its most recent amendment being made September 8th 2022."
Answered by AI
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