NCT02629549

A Phase 1, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor-alpha Positive Pituitary Adenoma

Terminated Phase 1 Last updated 2 August 2019

What this trial tests

Phase 1 trial testing OTL38 in Neoplasms in 33 participants. Terminated before completion.

Timeline

1 October 2015

Primary endpoint
3 August 2018

3 August 2018

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	33
Start date	1 October 2015
Primary completion	3 August 2018
Estimated completion	3 August 2018
Sites	1 location across United States

Drugs / interventions tested

• OTL38 — full drug profile →

Conditions studied

• Neoplasms — all drugs for Neoplasms →
• Pituitary Neoplasms — all drugs for Pituitary Neoplasms →

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with Neoplasms or Pituitary Neoplasms. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Detection of OTL38 in tumor tissue.
  Time frame: 60 months
  The detection of OTL38 uptake by tumor tissue will be made with the use of an imaging system that detects the presence of dye in tissue.
• Evaluate the ability of OTL38 to discern between tumorous tissue and normal, neural tissue.
  Time frame: 60 months
  Specificity and sensitivity of OTL38 will be calculated through the comparison of the video images gathered from the imaging system and the final pathology results from the surgical procedure.

Sponsor's own description

The primary end-point of the study is to determine the specificity and sensitivity of OTL38 in identifying pituitary adenomas when excited by an imaging probe. The investigators intend to enroll 50 patients in this study. The study is focusing on patients presenting with suspected pituitary adenomas who are considered to be good surgical candidates.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Beyond the margins: real-time detection of cancer using targeted fluorophores.
   Zhang RR, Schroeder AB, Grudzinski JJ, Rosenthal EL, et al · · 2017 · cited 321× · PMID 28094261 · DOI 10.1038/nrclinonc.2016.212
2. Oncologic Procedures Amenable to Fluorescence-guided Surgery.
   Tipirneni KE, Warram JM, Moore LS, Prince AC, et al · · 2017 · cited 116× · PMID 28045715 · DOI 10.1097/sla.0000000000002127
3. Fluorescence Image-Guided Surgery - a Perspective on Contrast Agent Development.
   Barth CW, Gibbs SL. · · 2020 · cited 79× · PMID 32255887 · DOI 10.1117/12.2545292
4. Single- versus Dual-Targeted Nanoparticles with Folic Acid and Biotin for Anticancer Drug Delivery.
   Jurczyk M, Jelonek K, Musiał-Kulik M, Beberok A, et al · · 2021 · cited 71× · PMID 33802531 · DOI 10.3390/pharmaceutics13030326
5. Fluorescent Probes for Imaging in Humans: Where Are We Now?
   Seah D, Cheng Z, Vendrell M. · · 2023 · cited 65× · PMID 37787658 · DOI 10.1021/acsnano.3c03564
6. Intraoperative near-infrared imaging with receptor-specific versus passive delivery of fluorescent agents in pituitary adenomas.
   Cho SS, Jeon J, Buch L, Nag S, et al · · 2019 · cited 34× · PMID 30554181 · DOI 10.3171/2018.7.jns181642
7. Intraoperative Tumor Detection Using Pafolacianine.
   Dindere ME, Tanca A, Rusu M, Liehn EA, et al · · 2022 · cited 30× · PMID 36361630 · DOI 10.3390/ijms232112842