RECRUITING

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

Conditions

Ovarian Cancer ALA Fluorescence guided surgery Gleolan

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3 Multicenter Study of Gleolan™ (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Suspected Newly Diagnosed or Recurrent Epithelial Ovarian Cancer

Quick Facts

Study Start:2024-05-30

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05804370

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Study will be limited to patients with the following diagnoses who plan to undergo surgical cytoreduction or interval debulking: a. primary diagnosis or high clinical suspicion of primary epithelial ovarian cancer, b. suspected epithelial, peritoneal, or fallopian tube cancer, c. recurrent epithelial ovarian cancer. 2. A pre-operative magnetic resonance image (MRI), positron emission tomography (PET), or computed tomography (CT) ≤ 30 days of study enrollment documenting a suspected tumor or suspected recurrence of tumor for which surgical debulking is indicated and has been planned. 3. Females (only) age ≥ 18 years. 4. Study participants must have normal organ and bone marrow function and be appropriate surgical candidates per site SoC. 5. Study participant must have recording of each parameter as defined below: 6. The study subject t must demonstrate the ability to understand the informed consent document and the willingness and ability to sign a written informed consent document. The study consent documents will be prepared in English and Spanish. Translation for non-English speaking participants will be provided as appropriate by institution, as required. 7. Women of childbearing potential must agree to use highly effective forms of contraception for at least 42 days after the one-time use of the Gleolan study drug.	1. Patient is to undergo laparoscopy and their surgeon believes it is unlikely that laparotomy/debulking will occur. 2. Hypersensitivity to aminolevulenic acid (ALA) or porphyrins. 3. Acute or chronic types of porphyria. 4. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness. 5. Patient has had chemotherapy, tumor resection or radiation treatment within 21 days prior to surgery. 6. Social or medical situations that would limit compliance with study requirements (e.g. ability to travel for follow-up or inability to obtain appropriate pre-op MRI, PET, or CT. 7. Women who are pregnant or plan to become pregnant during study participation. 8. Simultaneous participation in another investigational treatment trial in the 21 days directly preceding or after study drug administration. 9. Simultaneous use of other potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period. 10. Unwillingness by study participant to sign consent or return for subsequent visits following surgery. 11. Any condition that in the opinion of the Investigator would exclude the study participant as a viable candidate for this study.

Inclusion Criteria

Exclusion Criteria

1. Study will be limited to patients with the following diagnoses who plan to undergo surgical cytoreduction or interval debulking: a. primary diagnosis or high clinical suspicion of primary epithelial ovarian cancer, b. suspected epithelial, peritoneal, or fallopian tube cancer, c. recurrent epithelial ovarian cancer.
2. A pre-operative magnetic resonance image (MRI), positron emission tomography (PET), or computed tomography (CT) ≤ 30 days of study enrollment documenting a suspected tumor or suspected recurrence of tumor for which surgical debulking is indicated and has been planned.
3. Females (only) age ≥ 18 years.
4. Study participants must have normal organ and bone marrow function and be appropriate surgical candidates per site SoC.
5. Study participant must have recording of each parameter as defined below:
6. The study subject t must demonstrate the ability to understand the informed consent document and the willingness and ability to sign a written informed consent document. The study consent documents will be prepared in English and Spanish. Translation for non-English speaking participants will be provided as appropriate by institution, as required.
7. Women of childbearing potential must agree to use highly effective forms of contraception for at least 42 days after the one-time use of the Gleolan study drug.

1. Patient is to undergo laparoscopy and their surgeon believes it is unlikely that laparotomy/debulking will occur.
2. Hypersensitivity to aminolevulenic acid (ALA) or porphyrins.
3. Acute or chronic types of porphyria.
4. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.
5. Patient has had chemotherapy, tumor resection or radiation treatment within 21 days prior to surgery.
6. Social or medical situations that would limit compliance with study requirements (e.g. ability to travel for follow-up or inability to obtain appropriate pre-op MRI, PET, or CT.
7. Women who are pregnant or plan to become pregnant during study participation.
8. Simultaneous participation in another investigational treatment trial in the 21 days directly preceding or after study drug administration.
9. Simultaneous use of other potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period.
10. Unwillingness by study participant to sign consent or return for subsequent visits following surgery.
11. Any condition that in the opinion of the Investigator would exclude the study participant as a viable candidate for this study.

Contacts and Locations

Study Contact

Kristina Hadley, MSN, RN

CONTACT

425-530-7040

khadley@nxdevcorp.com

Ron Mims

CONTACT

505-681-3537

rmims@nxdevcorp.com

Principal Investigator

Kristina Butler, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

John McBroom, MD

PRINCIPAL_INVESTIGATOR

Luminis Health

Study Locations (Sites)

Luminis Health Anne Arundel Medical Center

Annapolis, Maryland, 21401

United States

Collaborators and Investigators

Sponsor: NX Development Corp

Kristina Butler, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic
John McBroom, MD, PRINCIPAL_INVESTIGATOR, Luminis Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-30

Study Completion Date2026-05

Study Record Updates

Study Start Date2024-05-30

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

ALA
Fluorescence guided surgery
Gleolan
Ovarian cancer

Additional Relevant MeSH Terms

Ovarian Cancer