NCT02317705

A Phase 2, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer

Completed Phase 2 Results posted Last updated 24 May 2022

What this trial tests

Phase 2 trial testing OTL38 in Ovarian Cancer in 48 participants. Completed in 1 November 2015.

Timeline

1 December 2014

Primary endpoint
1 November 2015

1 November 2015

Quick facts

Lead sponsor	On Target Laboratories, LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	48
Start date	1 December 2014
Primary completion	1 November 2015
Estimated completion	1 November 2015
Sites	4 locations across United States

Drugs / interventions tested

• OTL38 — full drug profile →
• Near infrared camera imaging system
• Laparotomy

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

On Target Laboratories, LLC — full company profile →

Who can join

18 and older, female only, with Ovarian Cancer. 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.

• Sensitivity of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.
  Time frame: Day of Surgery (Day 1)
  Sensitivity for the detection of folate receptor-alpha positive (FRAP) ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAO ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by the pathology/ and immunohistochemistry lab (TP+FN). 95% lower one-s
• Positive Predictive Value (PPV) of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.
  Time frame: Day of Surgery (Day 1)
  PPV for the detection of FRAP ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAP ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by fluorescent light (TP + FP). 95% lower one-sided confidence interval was used.

Sponsor's own description

This study is being done to:

* test the safety of OTL38
* see if OTL38 helps light up the cancer when viewed with the special camera system
* test the safety of the special camera system for use along with OTL38 during surgery

Publications & conference data

8 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. A practical guide for the use of indocyanine green and methylene blue in fluorescence-guided abdominal surgery.
   van Manen L, Handgraaf HJM, Diana M, Dijkstra J, et al · · 2018 · cited 214× · PMID 29938401 · DOI 10.1002/jso.25105
3. A Bright Future for Precision Medicine: Advances in Fluorescent Chemical Probe Design and Their Clinical Application.
   Garland M, Yim JJ, Bogyo M. · · 2016 · cited 171× · PMID 26933740 · DOI 10.1016/j.chembiol.2015.12.003
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. Tumor hypoxia directed multimodal nanotherapy for overcoming drug resistance in renal cell carcinoma and reprogramming macrophages.
   Alsaab HO, Sau S, Alzhrani RM, Cheriyan VT, et al · · 2018 · cited 60× · PMID 30179778 · DOI 10.1016/j.biomaterials.2018.08.053
7. Folate Receptor Alpha-A Novel Approach to Cancer Therapy.
   Gonzalez T, Muminovic M, Nano O, Vulfovich M. · · 2024 · cited 52× · PMID 38256120 · DOI 10.3390/ijms25021046
8. CD44 directed nanomicellar payload delivery platform for selective anticancer effect and tumor specific imaging of triple negative breast cancer.
   Wang Z, Sau S, Alsaab HO, Iyer AK. · · 2018 · cited 47× · PMID 29678787 · DOI 10.1016/j.nano.2018.04.004