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Mesothelioma Clinical Trials

EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer

This study is currently recruiting patients.

Sponsored by

University of Pennsylvania Cancer Center
For more information:National Cancer Institute (NCI)

RATIONALE: Diagnostic procedures using EF5 to detect oxygen level and blood vessels in tumor cells may help to improve the way photodynamic therapy is given.

PURPOSE: Clinical trial to study the effectiveness of EF5 in detecting oxygen level and blood vessels in tumor cells of patients who are undergoing photodynamic therapy for intraperitoneal or pleural cancer.

Condition Treatment or Intervention
malignant ascites
peritoneal cavity cancer
advanced malignant mesothelioma
localized malignant mesothelioma
recurrent malignant mesothelioma
Drug: EF5
Procedure: diagnostic test
Procedure: fluorescent antibody technique
Procedure: immunohistochemistry

This is a Phase II test

  • In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.  

Study Type: Interventional
Study Design: Diagnostic

Official Title: Study of the Etanidazole Derivative EF5 for the Detection of Hypoxia and Vascularity in Patients With Intraperitoneal or Pleural Malignancies Treated With Photodynamic Therapy

Further Study Details: 


  • Determine the level of hypoxia through etanidazole derivative EF5 binding in patients with intraperitoneal or pleural malignancies treated with photodynamic therapy.
  • Determine the microvascular density in this patient population.
  • Determine the relationships between levels of hypoxia, measures of microvascular density, and photosensitizer levels in this patient population.
  • Correlate hypoxia and photosensitizer levels with clinical outcome in this patient population.
  • Determine the toxic effects of EF5 in this patient population.

OUTLINE: This is a multicenter study.

Patients receive etanidazole derivative EF5 IV over 1-2 hours. Approximately 48 hours after EF5 administration, patients with intraperitoneal tumors undergo surgical resection. Patients with pleural tumors undergo surgical resection approximately 24 hours after EF5 administration. Tumors are then analyzed for EF5 binding and microvascular density by immunohistochemistry and fluorescent antibody techniques.

Patients are followed at 2 weeks and at 30-45 days post EF5 infusion.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 2-3 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both



  • Histologically confirmed intraperitoneal or pleural malignancy
  • Currently enrolled on 1 of 3 photodynamic therapy trials (UPCC-2997, UPCC-4997, or UPCC-05503)
  • Plan to undergo surgery for treatment on one of these protocols
  • Patients with suspected recurrent disease undergoing surgery for diagnosis and debulking allowed if frozen section shows malignant disease
  • No active extra-abdominal metastatic disease and/or intrahepatic involvement secondary to metastatic carcinoma
  • No borderline tumors of low malignant potential
  • No abdominal disease that cannot be debulked to less than 5 mm residual disease in maximal dimension 

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