Endometrial CancerEarly Phase 1NCT01979003
Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
A Early Phase 1 study testing Fluorescein in people with Endometrial Cancer, run by University of Arkansas at 1 site in United States.
Trial summary
To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in revealing the depth of endometrial cancer invasion. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Fluorescein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 30 Jun 2021
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Documented endometrial cancer and scheduled for hysterectomy as part of their treatment.
- No known allergy to fluorescein dye
- Ability to understand and sign informed consent
- 18 years of age or older
Who cannot join
- Prior hysterectomy
- Known sensitivity to fluorescein dye
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: A Pilot Study to Determine the Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in revealing the depth of endometrial cancer invasion.
Read the detailed description
All research participants will receive fluorescein injection through their existing intravenous line during their operative procedure for endometrial cancer staging. This will consist of one ampule (5 cc) injected intravenously prior to ligation of the uterine arteries. After the uterus is removed it will be sent to surgical pathology for evaluation as per routine care. The pathologist will open the uterus and evaluate the endometrium. He or she will then cut into the myometrium in an area most suspicious for invasion. The cross section of the myometrium and endometrium will be photographed while exposed to a Woods lamp. The normal myometrium will have a yellow fluorescent appearance under the Woods lamp. The cancerous tissue will have minimal fluorescence. The measurement will be taken estimating the depth of invasion of the cancer into the myometrium on the basis of its physical appearance under the Woods lamp. Cross-sectioning of the uterus is routine procedure by pathology for the intra-operative evaluation of endometrial cancer. This information routinely is provided in order to determine if lymph node staging is necessary.
The area that was measured and photographed will then be prepared for a frozen section to document depth of invasion. This is the standard procedure performed during an endometrial staging. The depth of invasion on the frozen section will be recorded. This same area will undergo histologic confirmation by permanent pathology to determine depth of invasion. The frozen section is part of routine standard of care in evaluation of endometrial cancer.
- Conditions
- Endometrial Cancer
- Being tested
- Fluorescein
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoresceinDrug
| Study group | Role | What they receive |
|---|---|---|
| Fluorescein Injection | Experimental | All research participants will receive fluorescein injection through existing intravenous line during the operative procedure. This will consist of one ampule (5 cc) injected intravenously 5- 10 minutes prior to ligation of the uterine arteries. Receives: Drug: Fluorescein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization
Cancerous tissue will be measured to estimate the depth of invasion on the basis of physical appearance after receiving fluorescein injection prior to surgery. For each study subject, the paired difference in invasion depths determined using the Systemic Fluorescein Injection (SFI) versus Frozen Section (FS) methods will be calculated and expressed as a percentage of the FS-based invasion depth.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startSep 2014
- Primary completion2 Oct 2019
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Burnett, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979003
- Sponsor's protocol ID
- 202459
- Status last verified
- Nov 2021
- First submitted
- 18 Oct 2013
- Last updated
- 24 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
- ClinicalTrials.gov ID
- NCT01979003
- Acronym / sponsor ID
- 202459
- Conditions
- Endometrial Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Posted 10 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in revealing the depth of endometrial cancer invasion.
Detailed description
All research participants will receive fluorescein injection through their existing intravenous line during their operative procedure for endometrial cancer staging. This will consist of one ampule (5 cc) injected intravenously prior to ligation of the uterine arteries. After the uterus is removed it will be sent to surgical pathology for evaluation as per routine care. The pathologist will open the uterus and evaluate the endometrium. He or she will then cut into the myometrium in an area most suspicious for invasion. The cross section of the myometrium and endometrium will be photographed while exposed to a Woods lamp. The normal myometrium will have a yellow fluorescent appearance under the Woods lamp. The cancerous tissue will have minimal fluorescence. The measurement will be taken estimating the depth of invasion of the cancer into the myometrium on the basis of its physical appearance under the Woods lamp. Cross-sectioning of the uterus is routine procedure by pathology for the intra-operative evaluation of endometrial cancer. This information routinely is provided in order to determine if lymph node staging is necessary.
The area that was measured and photographed will then be prepared for a frozen section to document depth of invasion. This is the standard procedure performed during an endometrial staging. The depth of invasion on the frozen section will be recorded. This same area will undergo histologic confirmation by permanent pathology to determine depth of invasion. The frozen section is part of routine standard of care in evaluation of endometrial cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescein Injection | Experimental | Drug: FluoresceinAll research participants will receive fluorescein injection through existing intravenous line during the operative procedure. This will consist of one ampule (5 cc) injected intravenously 5- 10 minutes prior to ligation of the uterine arteries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented endometrial cancer and scheduled for hysterectomy as part of their treatment.
- No known allergy to fluorescein dye
- Ability to understand and sign informed consent
- 18 years of age or older
Key exclusion criteria (2 listed)
- Prior hysterectomy
- Known sensitivity to fluorescein dye
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 |
|---|---|---|
| Fluorescein | Drug | Fluorescein Injection |
Primary outcome
Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization
Time frame: 1 day
Cancerous tissue will be measured to estimate the depth of invasion on the basis of physical appearance after receiving fluorescein injection prior to surgery. For each study subject, the paired difference in invasion depths determined using the Systemic Fluorescein Injection (SFI) versus Frozen Section (FS) methods will be calculated and expressed as a percentage of the FS-based invasion depth.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alexander Burnett, MD principal investigator
University of Arkansas
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 Fluorescein in people with Endometrial Cancer, run by University of Arkansas 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 4 inclusion and 2 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 24 Feb 2022. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization (time frame: 1 day). 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 24 Feb 2022.