8 completed, 6 recruiting, 1 not yet recruiting, 1 terminated. 4 Phase 1, 4 Phase 2, 3 Phase 3, 2 Early Phase 1, 2 Phase 4.
Follow this drug Literature Review of Pafolacianine trials Research Report on Pafolacianine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| CYTALUX Dose Extension Study CYTALUX (pafolacianine) injection - Cancer in the Lung, Ovarian Cancer | Phase 4 | Not yet recruiting | On Target Laboratories, LLC | 106 | 2026-08-15 | 2026-08-18 |
| CYTALUX for Intraoperative Imaging of Patients With Endometrial Cancer CYTALUX™ (pafolacianine), 1788 4K Camera System with Advanced Imaging Modality - Endometrial Cancer, Near Infrared Fluorescence Imaging | Early Phase 1 | Recruiting | Abramson Cancer Center at Penn Medicine | 10 | 2025-10-18 | 2025-12-12 |
| Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™) CYTALUX™ (pafolacianine) - Gastrointestinal Cancer, Gastric Cancer | Phase 4 | Recruiting | Cedars-Sinai Medical Center | 15 | 2025-09-05 | 2025-09-15 |
| Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer. CYTALUX™ (pafolacianine) injection preoperatively - Esophageal Cancer, Gastrointestinal Cancers | Phase 2 | Recruiting | John Waters | 50 | 2025-08-19 | 2026-06-05 |
| An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors Biospecimen Collection, Near Infrared Imaging, Pafolacianine Sodium - Childhood Malignant Solid Neoplasm, Childhood Malignant Thoracic Neoplasm | Phase 3 | Recruiting | Mayo Clinic | 20 | 2025-04-15 | 2026-04-01 |
| PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging - Gastrointestinal Cancer, Peritoneal Carcinomatosis | Early Phase 1 | Recruiting | University of California, Irvine | 10 | 2024-11-13 | 2026-02-27 |
| CYTALUX™for the Intraoperative Imaging of Prostate Cancer Cytalux™ (pafolacianine) for fluorescent imaging, Image Guided Surgery - Prostate Cancer | Phase 2 | Completed | Indiana University | 9 | 2024-09-19 | 2026-06-01 |
| Safety and Feasibility of Intraoperative Visualization With Cytalux in Children Cytalux - Osteosarcoma, Pulmonary Metastasis | Phase 1 | Recruiting | Ann & Robert H Lurie Children's Hospital of Chicago | 10 | 2024-04-08 | 2026-06-05 |
| OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer OTL38, intraoperative imaging camera system - Ovarian Cancer | Phase 1 | Withdrawn | Abramson Cancer Center at Penn Medicine | 2022-05-28 | 2022-06-27 | |
| ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting OTL38 for Injection, Near infrared camera imaging system - Lung Neoplasms, Lung Cancer | Phase 3 | Completed | On Target Laboratories, LLC | 112 | 2020-03-26 | 2023-03-23 |
| OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer OTL38, near infrared camera imaging system, laparotomy - Ovarian Cancer | Phase 3 | Completed | On Target Laboratories, LLC | 140 | 2018-01-26 | 2022-02-04 |
| OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules OTL38 for Injection, Near infrared camera imaging system, Endoscopic or Thoracic Surgery - Lung Neoplasms, Lung Cancer | Phase 2 | Completed | On Target Laboratories, LLC | 100 | 2017-05-04 | 2023-03-24 |
| Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry OTL38, ICG - Bladder Cancer, Gastric Cancer | Completed | University of Pennsylvania | 291 | 2016-07-01 | 2021-06-18 | |
| Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma OTL38, Intraoperative fluorescence imaging system - Renal Cell Carcinoma | Not applicable | Completed | Chandru Sundaram | 14 | 2015-12-29 | 2020-02-25 |
| Intraoperative Imaging of Pituitary Adenomas by OTL OTL38 - Neoplasms, Pituitary Neoplasms | Phase 1 | Terminated | University of Pennsylvania | 33 | 2015-10-01 | 2019-08-06 |
| Intraoperative Imaging of Pulmonary Nodules by OTL38 OTL38 - Neoplasms | Phase 1 | Completed | University of Pennsylvania | 262 | 2015-05-01 | 2022-06-28 |
| Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer OTL38, Near infrared camera imaging system, Laparotomy - Ovarian Cancer | Phase 2 | Completed | On Target Laboratories, LLC | 48 | 2014-12-01 | 2022-06-21 |
Ovarian Neoplasms (4) · Gastrointestinal Neoplasms (3) · Lung Neoplasms (3) · Esophageal Neoplasms (2) · Neoplasms (2) · Stomach Neoplasms (2) · Appendiceal Neoplasms (1) · Carcinoma, Renal Cell (1) · Endometrial Neoplasms (1) · Head and Neck Neoplasms (1) · Osteosarcoma (1) · Pelvic Neoplasms (1) · Peritoneal Neoplasms (1) · Pituitary Neoplasms (1) · Prostatic Neoplasms (1)
On Target Laboratories, LLC (5) · University of Pennsylvania (3) · Abramson Cancer Center at Penn Medicine (2) · Ann & Robert H Lurie Children's Hospital of Chicago (1) · Cedars-Sinai Medical Center (1) · Chandru Sundaram (1) · Indiana University (1) · John Waters (1) · Mayo Clinic (1) · University of California, Irvine (1)
United States (16) · Netherlands (2)
Sunil Singhal, MD (3) · Sunil Singhal (2) · Chandru P. Sundaram, MD (1) · Clinton Bahler, MD (1) · Janos Tanyi, MD (1) · John Waters, M.D. (1) · Maheswari Senthil, MD (1) · Miguel Burch, MD (1) · Stephanie F. Polites, MD, MPH (1) · Timothy Lautz, MD (1)