Status:

WITHDRAWN

Case Analysis on Real Life Incidence of Photodynamic Therapy (PDT) Safety Outcomes

Lead Sponsor:

Pinnacle Biologics Inc.

Conditions:

Esophageal Cancer

Lung Cancer

Eligibility:

All Genders

18+ years

Brief Summary

Three main adverse reactions, namely photosensitivity (reaction that is similar to sunburn), oesophageal stenosis (narrowing or closure of the food pipe), perforation of the treated area (a tear or pu...

Detailed Description

Patients will be enrolled in the registry upon injection of the porfimer sodium. During normal medical examination, criteria for entry onto the registry will be verified to confirm eligibility, and me...

Eligibility Criteria

Inclusion

  • Patients scheduled to undergo PDT with Photofrin
  • Patients must have the mental, literate, and legal ability to give a written informed consent, which must comply with the International Conference on Harmonization (ICH) guidelines and local requirements.

Exclusion

  • Patients treated with Photosan®
  • Patients being treated with any investigational drug or participating in any interventional studies, with the exception of investigational photoprotection measures.
  • Patients who are unable or unwilling to complete the follow-up evaluations required for the registry.

Key Trial Info

Start Date :

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01203163

Last Update

May 9 2012

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