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A Phase 3, Randomized, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

Topic of Study: Ovarian Cancer
Sponsor: On Target Laboratories Inc
Principal Investigator: Teresa Diaz-Montes, M.D., 410-332-9250, Armando Sardi, M.D., 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-332-9294
For More Information: 410-332-9294 or msittig@mdmercy.com
Coordinated Through: The Gynecologic Oncology Center at Mercy and Surgical Oncology at Mercy

The Phase 3 study is to confirm the efficacy of OTL38 in combination with fluorescent light to detect additional Folate Receptor-positive (FR+) ovarian cancer lesions not detected by palpation and visualization under normal light in patients with FR+ ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery. (Clinicaltrials.gov ID#: NCT03180307)

Ovarian, Fallopian Tube, and Primary Peritoneal Cancers

Topic of Study: Gynecologic Cancer
Principal Investigator: Teresa Diaz-Montes, M.D., 410-332-9250, Armando Sardi, M.D., 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-332-9294
For More Information: 410-332-9329 or 410-332-9294
Coordinated Through: The Gynecologic Oncology Center at Mercy and Surgical Oncology at Mercy

The purpose of this phase II trial is to determine the toxicity and post-operative complications related to cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) as an initial treatment option for patients with ovarian, fallopian tube, or primary peritoneal cancers and its impact on quality of life.  Subjects will be randomized to one of two treatment groups: CRS with HIPEC followed by combination chemotherapy, carboplatin and paclitaxel, or CRS only followed by combination chemotherapy carboplatin and paclitaxel.

Protocol Title and ClinicalTrials ID#: A phase II randomized study: Outcomes after cytoreductive surgery (CRS) with or without carboplatin hyperthermic intraperitoneal chemotherapy (HIPEC) followed by systemic chemotherapy with carboplatin and paclitaxel as initial treatment of ovarian, fallopian tube, and primary peritoneal cancer. NCT02124421

Development of Patient-derived Tumorgrafts as a Model for the Discovery of Biomarkers and Therapeutic Approaches for Gynecological Tumors

Topic of Study: Gynecologic Cancer
Principal Investigator: Teresa Diaz-Montes, M.D., 410-332-9250
Research Coordinator: Michelle Sittig, RN or Angie Gahres, BSN, RN at 410-332-9294
For More Information: 410-332-9294
Coordinated Through: The Gynecologic Oncology Center at Mercy and Johns Hopkins University, Oncology - Cancer Prevention and Control

The objective of this study is to collect patient specimens prospectively (tumor, blood, vaginal swab, and urine sample) from benign, high risk, and malignant surgeries in order to develop diagnostic biomarkers and targeted anticancer agents for gynecologic tumors. http://lifegenedna.com/

Meet Our Doctors: Gynecologic Oncology Center
The Institute for Gynecologic Care at Mercy - Baltimore, MD
Dwight Im, M.D.

A 2018 TOP DOC
Dr. Dwight Im is internationally recognized for his skill in gynecologic robotic surgery and serves as Director for The Neil B. Rosenshein, M.D., Institute for Gynecologic Care, The Gynecologic Oncology Center and Mercy's National Institute of Robotic Surgery.

See all Gynecologic Oncologists ›