CYTALUX for Endometrial Cancer

(CYTALUX ISS Trial)

Recruiting at 1 trial location

Overseen By Joseph Agyemang

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Pregnancy, Anaphylactic reactions, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called CYTALUX, which helps doctors better visualize cancer during endometrial cancer surgery. The main goal is to ensure the drug's safety and effectiveness in detecting cancer. Individuals diagnosed with endometrial cancer and planning surgery might be suitable candidates. Participants must be willing to stop taking folate or folic acid supplements shortly before the trial. As an Early Phase 1 trial, participants will be among the first to receive this new treatment, contributing to understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop taking folate or folic acid supplements at least 48 hours before receiving the study drug. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that CYTALUX is likely to be safe for humans?

Research has shown that CYTALUX (pafolacianine) underwent safety testing in other clinical trials. Common side effects include nausea in 13% of patients and vomiting in 5%. Abdominal pain and flushing each occurred in about 2% of patients. These side effects are mostly mild and manageable. In one study, about 30% of patients experienced drug-related side effects, with nausea and abdominal pain being the most common.

CYTALUX has already received FDA approval for other uses, suggesting it is generally well-tolerated. This ongoing research aims to confirm its safety and effectiveness in detecting endometrial cancer during surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for endometrial cancer, which typically involve surgery, chemotherapy, or radiation, CYTALUX (pafolacianine) is unique because it uses a special fluorescent dye that helps surgeons visualize cancerous tissue more clearly during surgery. This innovative approach allows for more precise removal of tumors, potentially improving surgical outcomes. Researchers are excited about CYTALUX because it offers a new way to enhance the effectiveness of existing surgical techniques, potentially leading to better recovery and prognosis for patients.

What evidence suggests that CYTALUX is effective for detecting endometrial cancer?

Research shows that CYTALUX (pafolacianine), administered to participants in this trial, helps surgeons locate cancer during operations. In studies with ovarian cancer, CYTALUX has effectively provided real-time images, highlighting cancerous tissues for easier identification and removal. This enables doctors to perform more precise surgeries, crucial for cancer treatment. Although specific data on endometrial cancer is still being collected, success in similar cancers suggests potential benefits. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing surgery for endometrial cancer. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.

Inclusion Criteria

My primary diagnosis is endometrial cancer.

I am scheduled for surgery to treat endometrial cancer.

Provision of signed and dated informed consent form

Exclusion Criteria

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

Pregnancy or positive pregnancy test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 30 days

1 visit (in-person)

Study Drug Infusion

Participants receive CYTALUX (pafolacianine) infusion up to 7 days before surgery

Up to 7 days

1 visit (in-person)

Surgery

Participants undergo surgery with intraoperative imaging using CYTALUX and a special camera system

1 day

1 visit (in-person)

Post-operation Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

1 visit (in-person or phone)

What Are the Treatments Tested in This Trial?

Interventions

• CYTALUX

Trial Overview

The trial is testing CYTALUX (pafolacianine), an investigational drug used alongside a special camera system to improve detection of cancer during surgery in patients with endometrial cancer.

How Is the Trial Designed?

Group I: CYTALUX™ (pafolacianine) injection and standard care laparoscopic evaluation of disease. Experimental Treatment 2 Interventions

single dose, open-label, pilot study of single dose of CYTALUX (pafolacianine) injection

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07278986

CYTALUX for Intraoperative Imaging of Patients With ...

The research study is being done to assess the safety and ability of an investigational drug called CYTALUX (pafolacianine) and a special camera ...

2.

trial.medpath.com

trial.medpath.com/clinical-trial/31a3bbad9c1d2e23/nct07278986-cytalux-pafolacianine-endometrial-cancer-surgery

CYTALUX for Intraoperative Imaging of Patients ... - MedPath

The research study is being done to assess the safety and ability of an investigational drug called CYTALUX (pafolacianine) and a special ...

3.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/86/NCT07278986/Prot_000.pdf

CLINICAL RESEARCH PROTOCOL

This study aims to explore the indication of CYTALUX™ (PAFOLACIANINE) for endometrial cancer. This study will evaluate the efficacy of CYTALUX™ ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10632580/

Pafolacianine, the magic wand of intraoperative imaging ...

The phase III study of pafolacianine as an adjunct has given positive results regarding its efficacy and safety for real-time intraoperative fluorescence ...

5.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2021/214907Orig1s000MultidisciplineR.pdf

214907Orig1s000 - accessdata.fda.gov

These results show the beneficial role of. Cytalux as an intraoperative adjunct to debulking surgery in patients with ovarian cancer, a disease with generally ...

6.

cytaluxhcp.com

cytaluxhcp.com/important-safety-information/

CYTALUX Important Safety Information

Adverse reactions that occurred in ≥ 1% of patients were: nausea (13%), vomiting (5%), abdominal pain (2%), flushing (2%), other infusion-related reactions (2%) ...

7.

cytalux.com

cytalux.com/important-safety-information/

CYTALUX Important Safety Information

The most common side effects of CYTALUX reported in clinical trials were nausea (13%), vomiting (5%), abdominal pain (2%), flushing (2%), other infusion-related ...