Trial Outcomes & Findings for Photoacoustic Imaging of the Ovary (NCT NCT02110277)

NCT ID: NCT02110277

Last Updated: 2018-03-13

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2018-03-13

Participant Flow

Participant milestones

Measure	PAI/Ultrasound Diagnostic Group 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: 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.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Photoacoustic Imaging of the Ovary

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 5 years

Population: Study prematurely terminated and no results analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: 0 participants analyzed since study was terminated prematurely.

To characterize the tissue images with pathologic diagnosis and to refine the system based on the characteristic features of in vivo imaging.

Outcome measures

Outcome data not reported

Adverse Events

PAI/Ultrasound Diagnostic Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Molly Brewer

UConn Health

Phone: 860-679-2100

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place