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New treatment option for Endometrial Cancer
Official title CYTALUX for Intraoperative Imaging of Patients With Endometrial Cancer
ClinicalTrials.gov ID: NCT07278986
What this study is testing
What is CYTALUX™ (pafolacianine)?
CYTALUX™ (pafolacianine) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The research study is being done to assess the safety and ability of an investigational drug called CYTALUX (pafolacianine) and a special camera system for the detection of cancer in patients undergoing surgical resection for endometrial cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Provision of signed and dated informed consent form
- Adult people 18 years of age and older
- Primary diagnosis of endometrial cancer
- Scheduled to undergo surgery for endometrial cancer
- Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
You likely can't join if
- Pregnancy or positive pregnancy test
- Any medical condition that in the opinion of the investigator could potentially jeopardize the safety of the subject
- History of anaphylactic reactions to products containing indocyanine green
- History of allergy to any of the components of CYTALUX
- Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol...
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Adult people 18 years of age and older
- Primary diagnosis of endometrial cancer
- Scheduled to undergo surgery for endometrial cancer
- Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
- Willingness to stop the use of folate or folic acid supplements at least 48 hours prior to infusion of study drug
- Pregnancy or positive pregnancy test
- Any medical condition that in the opinion of the investigator could potentially jeopardize the safety of the subject
- History of anaphylactic reactions to products containing indocyanine green
- History of allergy to any of the components of CYTALUX
- Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.