NCT02110277

Brief Summary

The purpose of this study is to develop technology to image the ovaries in order to better evaluate ovarian disease and to study how these experimental imaging techniques might work together or separately to improve our ability to detect ovarian cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable ovarian-cancer

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 13, 2018

Completed
Last Updated

March 13, 2018

Status Verified

November 1, 2017

Enrollment Period

2.2 years

First QC Date

April 7, 2014

Results QC Date

November 17, 2017

Last Update Submit

March 8, 2018

Conditions

Keywords

Ovarian CancerEpithelial ovarian cancer

Outcome Measures

Primary Outcomes (1)

  • To Measure Photoacoustic Imaging (PAI)/Ultrasound Signature From Ovaries Prior to Surgery Using the Ratio of Deoxy/Oxy Hb

    To develop a method of analyzing PAI ovarian tissue images measuring oxy and deoxy hemoglobin as well as the ratio of deoxy/oxy Hb to recognize the presence of ovarian abnormalities and compare changes seen with ultrasound to changes seen with PAI.

    5 years

Secondary Outcomes (1)

  • Pathologic Diagnosis and in Vivo Imaging

    5 years

Study Arms (1)

PAI/ultrasound Diagnostic Group

EXPERIMENTAL

These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.

Device: PAI/ultrasound Diagnostic Group

Interventions

These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.

PAI/ultrasound Diagnostic Group

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients, twenty one years or older, referred to the University of Connecticut for conditions necessitating oophorectomy.
  • Patients cannot be pregnant or wish to become pregnant.
  • Willingness to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UConn Health

Farmington, Connecticut, 06032, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Results Point of Contact

Title
Dr.Molly Brewer
Organization
UConn Health

Study Officials

  • Molly Brewer, MD

    UConn Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Obstetrics and Gynecology

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 10, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

March 13, 2018

Results First Posted

March 13, 2018

Record last verified: 2017-11

Locations