UnknownNot Applicable

ICG-Based Fluorescence Imaging for Intra-operative Detection of Endometriosis

Netherlands15 participantsStarted 2017-01

Plain-language summary

Endometriosis is a common disease for which the current gold standard for diagnosis is a diagnostic laparoscopy with histologic confirmation. However, during the diagnostic laparoscopy endometriotic lesions are hard to identify due to the many appearances of endometriosis. Our hypothesis is that the use of intra-operative near infrared fluorescence imaging will provide real time image enhancement for the detection of endometriotic lesions by using the different vasculature in the endometriotic lesions. This hypothesis will be tested in a prospective study with 15 patients scheduled for an elective diagnostic laparoscopy for suspected endometriosis.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients scheduled for elective laparoscopic surgery in which endometriosis is suspected * Able to understand the nature of the study and what will be required of them * Females * Age \>18years * Premenopausal * No history of impaired liver and renal function * No history of hypersensitivity or allergy to indocyanine green or iodide * No hyper-thyroidism or autonomic thyroid adenomas * Willing to participate Exclusion Criteria: * Not able to give written informed consent * Males * Aged \< 18 years * Pregnant or breast-feeding women * Known hypersensitivity or allergy to indocyanine green or iodide * Known hyper-thyroidism or autonomic thyroid adenomas * Not willing to participate

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of detected endometriotic lesions with Near Infrared Light versus with white light

Timeframe: during surgery

Trial details

NCT IDNCT03017989

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01

View on ClinicalTrials.gov More Endometriosis trials