Fibroid UterusEarly Phase 1NCT03927651
ICG to Assess Ovarian Perfusion
A Early Phase 1 study testing ICG in people with Fibroid Uterus and Endometriosis, run by Northwestern University at 1 site in United States.
Trial summary
To assess the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries during gynecologic surgery Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibroid Uterus, Endometriosis, Uterus Myoma
- What is being tested?
- ICG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 15 Nov 2022
- Phase
- Early 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients attending a preoperative visit at the Center for Comprehensive Gynecology who will undergo surgery.
Who cannot join
- Not able to comprehend and sign a written consent
- Patients with a history of allergy to iodides
- Patients history of renal failure or uremia, and those on dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Use of Intravenous Indocyanine Green (ICG) to Assess Ovarian Perfusion Using Infrared Imaging: A Feasibility Pilot Study
To assess the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries during gynecologic surgery
Read the detailed description
The purpose of this study is to determine the feasibility of intravenous ICG administration to facilitate assessments of ovarian vascular perfusion. Historically, assessment of ovarian perfusion has been performed visually or via ultrasound with Doppler evaluation. In patients with ovarian endometriomas, evidence of ovarian interstitial microvascular injury has been demonstrated similarly by the presence of low flow and high RI. The use of ICG to evaluate ovarian perfusion specifically has not been reported. The use of ICG for intraoperative perfusion assessment of the ovary could provide more information about the health of the ovary and inform the surgical approach to ovarian pathology.
ICG will be injected intravenously to assess ovarian perfusion in the presence or absence (control) of pathology. Near infrared fluorescence imaging will be used to illuminate the ICG. The extent of perfusion will be determined using digital imaging software.
- Conditions
- Fibroid Uterus, Endometriosis, Uterus Myoma, Uterine Fibroid, Uterine Adenomyosis, Endometrial Cyst
- Being tested
- ICG
- Medical subject headings
- Leiomyoma, Endometriosis, Myofibroma, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICGDrug
Also called Indocyanine green (ICG)
Indocyanine green (ICG) is a Food and Drug (FDA)-approved tricarbocyanine dye that is fluorescent under near-infrared (NIR) light. ICG solutions for injection often contain sodium iodide. ICG is water soluble and when introduced intravenously, it is bound by plasma proteins, namely albumin. The intravascular half-life of ICG is 3-4 minutes with rapid hepatic clearance.
| Study group | Role | What they receive |
|---|---|---|
| Administration of ICG | Experimental | ICG will be injected intravenously to assess ovarian perfusion in the presence or absence (control) of pathology. Near infrared fluorescence imaging will be used to illuminate the ICG. The extent of perfusion will be determined using digital imaging software. ICG will be stored at the NM Investigational Pharmacy and administered intravenously by the anesthesiologist at the direction of the surgeon during surgical procedure. Receives: Drug: ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of ovarian perfusion after ICG administration via fluorescent imaging
The investigators will be assessing the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries by imaging. During surgery ICG will be administered intravenously via a peripheral or central line at the direction of the surgeon by the anesthesiologist. The injected amount will be a 3 mL solution of reconstituted ICG that contains a 7.5 mg dose of ICG. This will be followed by a 10 mL bolus of normal saline for injection per the manufacturer's recommendation. The total dose of dye injected should not exceed 2 mg/kg.
Visibility of the ICG fluorescence should occur within 1-2 minutes with a duration of 20-120 minutes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start1 Jun 2019
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroid UterusStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy Milad, MD, Northwestern University
- Investigators
- Magdy Milad, MD,MS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927651
- Sponsor's protocol ID
- STU00208846
- Status last verified
- Apr 2023
- First submitted
- 9 Apr 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Use of Intravenous Indocyanine Green (ICG) to Assess Ovarian Perfusion Using Infrared Imaging: A Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT03927651
- Acronym / sponsor ID
- STU00208846
- Conditions
- Fibroid Uterus, Endometriosis, Uterus Myoma, Uterine Fibroid, Uterine Adenomyosis, Endometrial Cyst
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 25 Apr 2019 (actual)
- 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.
To assess the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries during gynecologic surgery
Detailed description
The purpose of this study is to determine the feasibility of intravenous ICG administration to facilitate assessments of ovarian vascular perfusion. Historically, assessment of ovarian perfusion has been performed visually or via ultrasound with Doppler evaluation. In patients with ovarian endometriomas, evidence of ovarian interstitial microvascular injury has been demonstrated similarly by the presence of low flow and high RI. The use of ICG to evaluate ovarian perfusion specifically has not been reported. The use of ICG for intraoperative perfusion assessment of the ovary could provide more information about the health of the ovary and inform the surgical approach to ovarian pathology.
ICG will be injected intravenously to assess ovarian perfusion in the presence or absence (control) of pathology. Near infrared fluorescence imaging will be used to illuminate the ICG. The extent of perfusion will be determined using digital imaging software.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of ICG | Experimental | Drug: ICGICG will be injected intravenously to assess ovarian perfusion in the presence or absence (control) of pathology. Near infrared fluorescence imaging will be used to illuminate the ICG. The extent of perfusion will be determined using digital imaging software. ICG will be stored at the NM Investigational Pharmacy and administered intravenously by the anesthesiologist at the direction of the surgeon during surgical procedure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients attending a preoperative visit at the Center for Comprehensive Gynecology who will undergo surgery.
Key exclusion criteria (3 listed)
- Not able to comprehend and sign a written consent
- Patients with a history of allergy to iodides
- Patients history of renal failure or uremia, and those on dialysis
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 |
|---|---|---|
| ICGAlso: Indocyanine green (ICG)Indocyanine green (ICG) is a Food and Drug (FDA)-approved tricarbocyanine dye that is fluorescent under near-infrared (NIR) light. ICG solutions for injection often contain sodium iodide. ICG is water soluble and when introduced intravenously, it is bound by plasma proteins, namely albumin. The intravascular half-life of ICG is 3-4 minutes with rapid hepatic clearance. | Drug | Administration of ICG |
Primary outcome
Assessment of ovarian perfusion after ICG administration via fluorescent imaging
Time frame: 2 years
The investigators will be assessing the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries by imaging. During surgery ICG will be administered intravenously via a peripheral or central line at the direction of the surgeon by the anesthesiologist. The injected amount will be a 3 mL solution of reconstituted ICG that contains a 7.5 mg dose of ICG. This will be followed by a 10 mL bolus of normal saline for injection per the manufacturer's recommendation. The total dose of dye injected should not exceed 2 mg/kg. Visibility of the ICG fluorescence should occur within 1-2 minutes with a duration of 20-120 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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.
Magdy Milad, MD,MS principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ICG in people with Fibroid Uterus and Endometriosis, run by Northwestern University at 1 site in United States.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 18 Apr 2023. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of ovarian perfusion after ICG administration via fluorescent imaging (time frame: 2 years). 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 18 Apr 2023.