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Compensation: Varies

Number of Visits: 2

Duration: 1 day

50 Participants Needed

CYTALUX for Cancer Detection

Overseen ByJohn Waters, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: John Waters

Disqualifiers: Anaphylaxis, Allergy to CYTALUX, others

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

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called CYTALUX (pafolacianine) to help doctors see cancer more clearly during surgery. The drug makes cancer cells light up under a special camera, aiding surgeons in spotting and removing cancerous tissue more effectively. It targets individuals with potential cancers in areas such as the stomach, pancreas, liver, or reproductive organs who plan to undergo tumor-removal surgery. Those needing surgery for these cancers might be suitable for this study. Participants must stop using folate or folic acid supplements before receiving the drug. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You will need to stop taking folate, folic acid, or folate-containing supplements 48 hours before receiving the study medication. The protocol does not specify if you need to stop other medications.

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

Research has shown that CYTALUX (pafolacianine) is generally safe. The FDA has approved this drug to help surgeons identify ovarian cancer tissues during surgery. Studies indicate that the side effects and risks of CYTALUX are similar for individuals with ovarian cancer and those with other cancer types.

While specific data on serious side effects is not yet available, current safety information does not reveal any major concerns for its approved uses. This trial is in its early stages, and researchers are still gathering detailed safety data for new applications. However, its existing FDA approval for another condition provides some reassurance about its safety.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Unlike the standard cancer detection methods that often rely on imaging techniques like MRI or CT scans, CYTALUX™ (pafolacianine) offers a unique approach by using a targeted fluorescent dye. This dye binds specifically to cancer cells, making them glow under a special light during surgery, which helps surgeons see and remove cancerous tissue more accurately. Researchers are excited about CYTALUX because it has the potential to improve surgical outcomes by ensuring more complete removal of tumors, reducing the likelihood of cancer recurrence. This innovative mechanism could make a significant difference in cancer detection and treatment, offering a new layer of precision that current methods lack.

What evidence suggests that CYTALUX might be an effective treatment for cancer detection?

Research has shown that CYTALUX (pafolacianine) can aid in detecting cancer during surgery. In one study, 28% of patients had cancerous areas invisible under normal light but detected using CYTALUX and a special camera. Another study found that pafolacianine identified additional cancer in 36% of patients with ovarian cancer that standard methods missed. The detection rate for ovarian cancer was 83%, with a 24.8% chance of false positives. This capability can help surgeons find more cancerous tissue that might otherwise be missed, potentially improving surgical outcomes.⁶ ⁷ ⁸ ⁹ ¹⁰

Who Is on the Research Team?

John Waters, M.D.

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

Adults diagnosed or highly suspected of having gastrointestinal, pancreatic, hepatobiliary, esophageal malignancies and gynecologic cancers who are scheduled for tumor resection surgery. Participants must be willing to stop taking folate supplements two days before receiving CYTALUX™ and provide written consent.

Inclusion Criteria

I am 18 years old or older.

I am willing to sign a consent form for the study.

I am willing to stop taking folate or folic acid supplements 48 hours before my treatment.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single IV dose of pafolacianine prior to surgery for intraoperative detection of malignant tissue

1 day

1 visit (in-person)

Surgery

Intraoperative NIR imaging is conducted to visualize and document fluorescent lesions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

CYTALUX (Pafolacianine)

Trial Overview The trial is testing CYTALUX™ (pafolacianine) injection's ability to make cancer cells glow under a special camera during surgery. This could help surgeons see and remove malignant tissue more effectively in patients undergoing cancer resection.

How Is the Trial Designed?

1Treatment groups

Experimental Treatment

Group I: CYTALUX™ (pafolacianine) injection groupExperimental Treatment1 Intervention

Single arm study, every patient receives the study intervention.

Find a Clinic Near You

Who Is Running the Clinical Trial?

John Waters

Lead Sponsor

On Target Laboratories, LLC

Industry Sponsor

Trials

Recruited

470+

Citations

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

Pafolacianine, the magic wand of intraoperative imaging ...Moreover, the sensitivity of detecting the ovarian cancer was 83% with a false-positive rate of 24.8%. As for the safety profile of pafolacianine, 30% (45 of ...

2.clinicaltrials.govclinicaltrials.gov/study/NCT07039526

Study Details | NCT07039526 | Single Dose Investigator ...Can CYTALUX™ (pafolacianine) injection used with near-infrared (NIR) fluorescent imaging improve the detection of malignant tissue in subjects undergoing ...

3.fda.govfda.gov/drugs/resources-information-approved-drugs/fda-approves-pafolacianine-identifying-malignant-ovarian-cancer-lesions

Pafolacianine for identifying malignant ovarian cancer ...Among these patients, 36 (26.9%) had at least one evaluable ovarian cancer lesion detected with pafolacianine that was not observed by standard ...

4.ontargetlabs.comontargetlabs.com/new-study-shows-cytalux-clinical-trial-findings-translate-to-the-real-world/

New Study Shows CYTALUX® Clinical Trial Findings ...Results showed that in 28 percent (11/39) of patients, the primary lesion was not detectable under visual inspection with white light but was ...

5.ascopubs.orgascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.5503

Phase 3, randomized, single-dose, open-label study to ...This phase 3 trial of pafolacianine sodium with NIRF imaging met its primary endpoint, intraoperatively identifying additional cancer not planned for resection.

6.cytalux.comcytalux.com/important-safety-information/

CYTALUX Important Safety InformationImportant safety information on the use of CYTALUX to help surgeons visualize ovarian cancer lesions during surgery.

7.cytaluxhcp.comcytaluxhcp.com/important-safety-information/

CYTALUX Important Safety InformationCYTALUX® is an FDA approved optical imaging agent indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian ...

8.accessdata.fda.govaccessdata.fda.gov/drugsatfda_docs/label/2022/214907s002lbl.pdf

Cytalux - accessdata.fda.govOverall, the safety profile observed in patients treated with CYTALUX 0.025 mg/kg was similar between patients with ovarian cancer and patients with known or ...

9.clinicaltrials.govclinicaltrials.gov/study/NCT06235125?term=PAFOLACIANINE&viewType=Table&rank=1

Study Details | NCT06235125 | Safety and Feasibility of ...CYTALUX (Pafolacianine) as a diagnostic tool during cancer resection has already been investigated in adults (approved NDA 214907), and no age-specific ...

10.cytalux.comcytalux.com/

CYTALUX® for ovarian cancer surgeryThere are no available human data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

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