Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
NX Development Corp
Study ID
NCT05804370
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gleolan — DRUG
    Gleolan is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX). The oral provision of Gleolan leads to a highly selective accumulation of PpIX in tumor cells. Following excitation with blue light (BL) (wavelength \[λ\] = 375 - 450 nm), the PpIX, which has accumulated selectively in tumor tissue, emits a red-violet light.

Study Details

This Phase 3 study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real-time detection and visualization of epithelial ovarian cancer tumors during debulking surgery. The study is planned to run for about 18 months with individual study participation lasting about two (2) weeks.

Key Dates

Start date
May 30, 2024
Status verified
Sep 2025
Primary completion
Jan 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
170 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patients Receiving Gleolan
    All patients in this arm will receive Gleolan and undergo intraoperative imaging

Primary Outcome Measure

To determine the clinical usefulness of Gleolan to detect epithelial ovarian cancer tissue not detected during SoC debulking surgery. [ Time Frame: Surgery (Day 1) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054
Courtney M. Nelson Clinical Research Coordinator
[email protected]
(480) 342-2000
Kristina Butler, MD (PRINCIPAL_INVESTIGATOR)
Luminis Health Anne Arundel Medical CenterAnnapolisMaryland21401-
University of MarylandBaltimoreMaryland21201
Nancy Tait Research Coordinator
[email protected]
410-328-3546
Dana Roque, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Methodist CampusRochesterMinnesota55905
Jainnee McCann Research Coordinator
[email protected]
(507) 538-5679
Amanika Kumar, MD (PRINCIPAL_INVESTIGATOR)
Mount SinaiNew YorkNew York10128
Neha Kumarley Research Coordinator
[email protected]
(212) 241-6500
Stephanie Blank, MD (PRINCIPAL_INVESTIGATOR)
WellSpan HealthYorkPennsylvania17403
Nicole Imamovic Research Coordinator
[email protected]
717-741-8019
Eav Lim, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Mayo Clinic Arizona· Phoenix, AZLuminis Health Anne Arundel Medical Center· Annapolis, MDUniversity of Maryland· Baltimore, MDMayo Clinic Methodist Campus· Rochester, MNMount Sinai· New York, NYWellSpan Health· York, PA

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