Study on Gleolan for Detecting Ovarian Cancer During Surgery

Sponsor: NX Development Corp

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05804370

Provider View

This clinical trial is testing the safety and effectiveness of Gleolan, a drug used to help surgeons see ovarian cancer tumors more clearly during surgery. The study will last about 18 months, but each participant will be involved for about two weeks.

Patient Parameters

Program Overview

The purpose of this study is to find out if Gleolan can safely and effectively help doctors see ovarian cancer tumors in real-time during surgery. This could improve the ability to remove tumors. The study will last around 18 months, but each participant will be involved for about two weeks.

Description

The study is divided into different parts:

  • Part A1: This is a training phase where doctors will learn how to use Gleolan and collect images to see how well it highlights tumors compared to the surrounding tissue. Participants will receive Gleolan and undergo a blue light assessment and tumor biopsy.

  • Part A2: Another training phase to refine the process and determine the number of participants needed for the next phase. Participants will receive Gleolan and undergo standard ovarian cancer surgery, followed by blue light assessment and biopsy.

  • Part B: This is the main part of the study where the safety and effectiveness of Gleolan in helping to see ovarian cancer tumors during surgery will be evaluated.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older with a primary diagnosis or high suspicion of ovarian cancer, or suspected peritoneal or fallopian tube cancer, or recurrent ovarian cancer.
  • Must have a recent MRI, PET, or CT scan showing a suspected tumor or recurrence that requires surgery.
  • Must have normal organ and bone marrow function and be suitable for surgery.
  • Must have specific blood test results within normal ranges.
  • Must understand and be willing to sign a consent form, available in English and Spanish.
  • Women of childbearing age must agree to use effective birth control for at least 42 days after taking Gleolan.

Exclusion Criteria

  • Patients who are only having a laparoscopy and not likely to have full surgery.
  • Allergies to aminolevulenic acid (ALA) or porphyrins.
  • Certain blood disorders like porphyria.
  • Uncontrolled illnesses such as infections, heart failure, or psychiatric conditions.
  • Recent chemotherapy, tumor removal, or radiation within 21 days before surgery.
  • Situations that prevent following study requirements, like travel issues or inability to get necessary scans.
  • Pregnant women or those planning to become pregnant during the study.
  • Participation in another trial within 21 days before or after this study.
  • Use of certain medications that increase sensitivity to light during the study period.
  • Unwillingness to sign consent or attend follow-up visits.
  • Any condition that the study doctor believes makes participation unsuitable.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.