EndometriosisNCT03017989
ICG-Based Fluorescence Imaging for Intra-operative Detection of Endometriosis
A study testing NIRF imaging in people with Endometriosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- NIRF imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2017to Sep 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- No history of hypersensitivity or allergy to indocyanine green or iodide
- No hyper-thyroidism or autonomic thyroid adenomas
- Willing to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6202
About this study
Official title: The Use of Indocyanine Green-Based Fluorescence Imaging for Intraoperative Detection of Peritoneal Endometriosis
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.
- Conditions
- Endometriosis
- Being tested
- NIRF imaging
- Keywords
- Near Infrared Fluorescence Imaging, Indocyanine green (ICG)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRF imagingDevice
Also called Near infrared fluorescence imaging
By using a fluorescence imaging device (with an adapted light source and camera), a fluorescent dye can be made visible. By injecting the fluorescent dye intravenously, the vascularization will be visible. Thereby, structures with altered vascularization are expected to 'light up' differently than the surrounding.
| Study group | Role | What they receive |
|---|---|---|
| NIRF imaging | Experimental | After the white light (WL) imaging, NIRF imaging will be performed. 2.5 mg of ICG will be administered i.v. up to 5 times if needed. The lesions identified in WL, are inspected in NIRF mode. The surgeon indicated whether the lesions are more easily identified in WL or the NIRF mode and scores the visibility on a 1-10 scale. Next, inspection will take place for lesions that are seen in NIRF mode but not in WL. Biopsies will be taken from the lesions and from normal tissue for reference and sent for histology. Evaluation will take place whether the lesions differ in histological characteristics Receives: Device: NIRF imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of detected endometriotic lesions with Near Infrared Light versus with white light
The number of lesions detected in near-infrared light will be compared to the number of endometriotic lesions seen in white light. Hereby, we aim to investigate whether all lesions seen in white light are also seen in NIRF light and whether NIRF light shows endometriotic lesions that were not visible in white light.
Measured: during surgery
Secondary outcomes (5)
Histological assessment of taken biopsies: assessment of localization of ICG uptake
Hereby, we aim to investigate whether the different histological subtypes of endometriosis light up differently in NIRF light. We interested in whether there is another localisation of ICG uptake at cellular level in the different histological subtypes.
Measured: biopsies taken during surgery, which are assessed during the 1th week after surgery
Time measurement
measuring the total operating time, and the extra time needed for fluorescence imaging
Measured: during the laparoscopic procedure
Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye
Complications during the diagnostic laparoscopy attributable to the imaging technique or dye are described here.
Measured: during surgery
Satisfaction of the surgeon with the technique
Immediately the surgeon will be asked whether he/she considered the use of NIRF imaging an useful additive to the procedure.
Measured: immediately after surgery
Histological assessment of taken biopsies: assessment Target to background ratio
The biopsies taken during surgery will be analysed together with the video recordings. Hereby, we aim to investigate whether the different histological subtypes of endometriosis light up differently in NIRF light. We interested in whether there is another target to background rato in the different histological subtypes.
Measured: biopsies taken during surgery, which are assessed during the 1th week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2019
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurents Stassen, M.D, Ph.D, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017989
- Sponsor's protocol ID
- NL54458.068.15
- Status last verified
- Mar 2019
- First submitted
- 3 Jan 2017
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Indocyanine Green-Based Fluorescence Imaging for Intraoperative Detection of Peritoneal Endometriosis
- ClinicalTrials.gov ID
- NCT03017989
- Acronym / sponsor ID
- NL54458.068.15
- Conditions
- Endometriosis
- Keywords
- Near Infrared Fluorescence Imaging, Indocyanine green (ICG)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Sep 2019 (estimated)
- First posted
- 11 Jan 2017 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIRF imaging | Experimental | Device: NIRF imagingAfter the white light (WL) imaging, NIRF imaging will be performed. 2.5 mg of ICG will be administered i.v. up to 5 times if needed. The lesions identified in WL, are inspected in NIRF mode. The surgeon indicated whether the lesions are more easily identified in WL or the NIRF mode and scores the visibility on a 1-10 scale. Next, inspection will take place for lesions that are seen in NIRF mode but not in WL. Biopsies will be taken from the lesions and from normal tissue for reference and sent for histology. Evaluation will take place whether the lesions differ in histological characteristics |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| NIRF imagingAlso: Near infrared fluorescence imagingBy using a fluorescence imaging device (with an adapted light source and camera), a fluorescent dye can be made visible. By injecting the fluorescent dye intravenously, the vascularization will be visible. Thereby, structures with altered vascularization are expected to 'light up' differently than the surrounding. | Device | NIRF imaging |
Primary outcome
Number of detected endometriotic lesions with Near Infrared Light versus with white light
Time frame: during surgery
The number of lesions detected in near-infrared light will be compared to the number of endometriotic lesions seen in white light. Hereby, we aim to investigate whether all lesions seen in white light are also seen in NIRF light and whether NIRF light shows endometriotic lesions that were not visible in white light.
5 secondary outcomes
Histological assessment of taken biopsies: assessment of localization of ICG uptake
Time frame: biopsies taken during surgery, which are assessed during the 1th week after surgery
Time measurement
Time frame: during the laparoscopic procedure
Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye
Time frame: during surgery
Satisfaction of the surgeon with the technique
Time frame: immediately after surgery
Histological assessment of taken biopsies: assessment Target to background ratio
Time frame: biopsies taken during surgery, which are assessed during the 1th week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Laurents Stassen, M.D, Ph.D principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRF imaging in people with Endometriosis, run by Maastricht University Medical Center at 1 site in Netherlands.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Mar 2019. 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 Netherlands. 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?
Results are not available in the source record.
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?
Number of detected endometriotic lesions with Near Infrared Light versus with white light (time frame: during surgery). 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 8 Mar 2019.