OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer

NCT04941378 | Withdrawn Phase 1 FDA Drug FDA Device

• 1 other identifier: UPCC 11818
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to compare the performance of different camera imaging systems in assessing the positive predictive values and sensitivity of OTL38 to detect folate positive ovarian cancer cancers using the gold standard of pathologic review.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Compare the performance of different camera imaging systems in assessing the positive predictive values

  The primary objective of the study is to compare the performance of different camera imaging systems in assessing the sensitivity and positive predictive value of OTL38 to detect folate positive ovarian cancers using the gold standard of pathologic review.

  Up to 4 weeks post surgery (completion of post-operative follow-up visit)

Study Arms (1)

OTL 38

EXPERIMENTAL

The study drug in question is an Investigational New Drug (IND), folate analog ligand conjugated with an indole cyanine green-like dye called OTL38. There will be a single dose of 0.025 mg/kg for intravenous injection over approximately 60 minutes, completed at least 1 hour prior to intraoperative imaging

Drug: OTL38; Device: intraoperative imaging camera system

Interventions

OTL38 DRUG

One time infusion of OTL38

OTL 38

intraoperative imaging camera system DEVICE

intraoperative imaging camera system

OTL 38

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients \> 18 years of age
• 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
• Good operative candidate as determined by clinical presentation and laboratory assessments
• Subject capable of giving informed consent and participating in the process of consent.

You may not qualify if:

• Pregnant women as determined by urinary or serum beta hCG.
• Patients with a history of allergy to any of the components of OTL38, including folic acid
• Known FR-negative ovarian cancer
• Patients with a known allergy to Benadryl
• Previous exposure to OTL38
• Vulnerable populations: the homeless, prisoners or not capable of participating in the consent process

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Pafolacianine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Sunil Singhal

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 28, 2021
• Study Start: May 28, 2022
• Primary Completion: May 28, 2022
• Study Completion: May 28, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

US (1)