Research into the detection of ovarian cancer during the operation with the fluorescent substance OTL38

Phase 1

• Conditions: Ovarian cancer; MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2018-004255-20-NL
• Lead Sponsor: On Target Laboratories, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-06
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 147

Inclusion Criteria

To be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below:
1. Female patients 18 years of age and older
2. Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer, and:
• Who are scheduled to undergo laparotomy for the debulking surgery
OR
• Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy
3. A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
4. Female patients of childbearing potential, or less than 2 years postmenopausal, agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
5. Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Patients will be excluded if they meet any of the exclusion criteria listed below:
1. Previous exposure to OTL38
2. Known FR-negative ovarian cancer
3. Planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy
4. Patients with known ovarian cancer miliary disease prior to surgery
5. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
6. History of anaphylactic reactions
7. History of allergy to any of the components of OTL38, including folic acid
8. Pregnancy or positive pregnancy test
9. Clinically significant abnormalities on the electrocardiogram (ECG)
10. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
11. Impaired renal function defined as eGFR< 50 mL/min/1.73m2
12. Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
13. Known Stage IV ovarian cancer with brain metastases
14. Received an investigational agent in another clinical trial within 30 days prior to surgery
15. Known sensitivity to fluorescent light

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified