Phase 4 Stomach Cancer Trial, Recruiting NCT07124351 Sponsor: Cedars-Sinai Medical Center Condition: Stomach Cancer
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Phase 4 Stomach Cancer Trial, Recruiting

NCT07124351
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older, of any sex
  • People who have been diagnosed with, or are strongly suspected of having, cancer of the stomach or oesophagus (gastroesophageal adenocarcinoma), based on CT, PET, or other scans (Cohort 1) — or people diagnosed with appendix cancer (appendiceal adenocarcinoma) where cancer spread to the lining of the abdomen is strongly suspected (Cohort 2)
  • People for whom surgery is planned — either to remove a stomach or oesophageal tumour, or to perform a keyhole procedure to assess how far the cancer has spread inside the abdomen
  • People who are willing to stop taking folate, folic acid, or any supplements containing folate at least 48 hours before receiving the study drug (CYTALUX)
  • People who are willing to provide written consent to participate in the research

Who may not be able to join:

  • People with any medical condition that the trial doctors believe could put them at risk during the study
  • People who have previously had a severe allergic reaction (anaphylaxis) to products containing indocyanine green, a dye used in near-infrared imaging — people with a history of severe allergic reactions of unknown cause will need further assessment before joining
  • People who have a known allergy to any ingredient in CYTALUX™ (pafolacianine) injection
  • People facing psychological, family, social, or geographical circumstances that may make it difficult to follow the study requirements or attend follow-up appointments
  • People with a known sensitivity to fluorescent light
  • Women who are pregnant or planning to become pregnant during the study period

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Miguel Burch, MD, Cedars-Sinai Medical Center

Phone: 310-423-1542

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Cedars-Sinai Medical Center
Registry
ClinicalTrials.gov
Start date
5 September 2025
Est. completion
1 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Feasibility of CYTALUX™ (pafolacianine) with near-infrared (NIR) fluorescent imaging

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov