Phase 2 Oesophageal Cancer Trial, Recruiting NCT07039526 Sponsor: John Waters Condition: Oesophageal Cancer
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Phase 2 Oesophageal Cancer Trial, Recruiting

NCT07039526
Recruiting Phase 2

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:

  • Adults aged 18 or older, of any gender
  • People who have been diagnosed with, or are strongly suspected to have, a cancer affecting the digestive system, pancreas, liver and bile ducts, oesophagus, or gynaecological organs, and where a specific surgical procedure (HIPEC/debulking) is being planned
  • People who are scheduled to have surgery to remove a tumour, or a keyhole procedure to assess how far the cancer has spread
  • 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, or whose legal guardian or representative is willing to do so on their behalf

Who may not be able to join:

  • People with a medical condition that the trial investigators believe could put their safety at risk (confirm with trial site)
  • 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 unexplained severe allergic reactions will need further assessment
  • People who have a known allergy to any ingredient in CYTALUX™ (pafolacianine) injection
  • People who have psychological, family, social, or location-related challenges that may make it difficult to follow the trial schedule or attend follow-up appointments

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 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: John Waters, M.D., University of Texas Southwestern Medical Center

Phone: 214-645-7700

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 2
Sponsor
John Waters
Registry
ClinicalTrials.gov
Start date
19 August 2025
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Proportion of subjects with one or more NIR fluorescence positive lesion not detected under normal light and/or palpation

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: 28 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