EndometriosisPhase 1Endo-lightNCT02975219
Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis
A Phase 1 study testing Bevacizumab-800CW in people with Endometriosis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Incomplete resection of endometriosis lesions often results in recurrence of symptoms and the need for repeated surgery, with considerable associated morbidity. The aim of this pilot project is to determine the feasibility of fluorescence imaging to improve the treatment of endometriosis in the future. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Endometriosis
- What is being tested?
- Bevacizumab-800CW
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2017to Jan 2019
- Phase
- Phase 1
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged ≥ 18 years
- Scheduled for surgery for the treatment of endometriosis
- WHO performance score of 0-2
- Written informed consent
- For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:
- A negative serum pregnancy test prior to receiving the tracer
- Willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter.
Who cannot join
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Pregnancy
- History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
- Significant renal, cardiac, or pulmonary disease (ASA III-IV)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Go M. van Dam, MD, PhD, +31 50 361 0183, g.m.van.dam@umcg.nl
Go M. van Dam, MD, PhD
About this study
Official title: Determine the Feasibility of Detecting Endometriosis During Surgery Using a Molecular Targeted Fluorescent Imaging Tracer
Incomplete resection of endometriosis lesions often results in recurrence of symptoms and the need for repeated surgery, with considerable associated morbidity. The aim of this pilot project is to determine the feasibility of fluorescence imaging to improve the treatment of endometriosis in the future.
- Conditions
- Endometriosis
- Being tested
- Bevacizumab-800CW
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab-800CWDrug
Also called Bevacizumab-IRDye800CW
4.5mg Bevacizumab-800CW will be administered intravenously three days prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 4.5mg Bevacizumab-800CW intravenously Receives: Drug: Bevacizumab-800CW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracer accumulation of bevacizumab-800cw in endometriosis lesions assessed by ex vivo measurement of the mean fluorescent intensity correlated to histopathology
Measured: within 6 months after surgery
Secondary outcomes (1)
Number of participants with treatment-related adverse events
Measured: within two weeks after tracer injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start1 May 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 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 University Medical Center GroningenThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G.M. van Dam, University Medical Center Groningen
- Investigators
- Gooitzen van Dam, prof dr, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975219
- Sponsor's protocol ID
- 2016/304
- Acronym
- Endo-light
- Status last verified
- Jun 2017
- First submitted
- 17 Nov 2016
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Feasibility of Detecting Endometriosis During Surgery Using a Molecular Targeted Fluorescent Imaging Tracer
- ClinicalTrials.gov ID
- NCT02975219
- Acronym / sponsor ID
- Endo-light / 2016/304
- Conditions
- Endometriosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 29 Nov 2016 (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.
Incomplete resection of endometriosis lesions often results in recurrence of symptoms and the need for repeated surgery, with considerable associated morbidity. The aim of this pilot project is to determine the feasibility of fluorescence imaging to improve the treatment of endometriosis in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Bevacizumab-800CW4.5mg Bevacizumab-800CW intravenously |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Females aged ≥ 18 years
- Scheduled for surgery for the treatment of endometriosis
- WHO performance score of 0-2
- Written informed consent
- For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:
Key exclusion criteria (4 listed)
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Pregnancy
- History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
- Significant renal, cardiac, or pulmonary disease (ASA III-IV)
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 |
|---|---|---|
| Bevacizumab-800CWAlso: Bevacizumab-IRDye800CW4.5mg Bevacizumab-800CW will be administered intravenously three days prior to surgery | Drug | Treatment group |
Primary outcome
Tracer accumulation of bevacizumab-800cw in endometriosis lesions assessed by ex vivo measurement of the mean fluorescent intensity correlated to histopathology
Time frame: within 6 months after surgery
1 secondary outcome
Number of participants with treatment-related adverse events
Time frame: within two weeks after tracer injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
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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.
Gooitzen van Dam, prof dr principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bevacizumab-800CW in people with Endometriosis, run by University Medical Center Groningen 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 7 inclusion and 4 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 27 Jun 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Gooitzen van Dam, prof dr (0503610183, g.m.van.dam@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracer accumulation of bevacizumab-800cw in endometriosis lesions assessed by ex vivo measurement of the mean fluorescent intensity correlated to histopathology (time frame: within 6 months after 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 27 Jun 2017.