Diffuse Optical Imaging With Indocyanine Green Solution in Imaging Pelvic Lymph Nodes in Patients With Stage II Prostate Cancer Undergoing Surgery

• Status: Completed
• Trial end date: 2018-02-07
• Target enrollment: 0
• Participant gender: Male

Summary

This clinical trial studies diffuse optical imaging with indocyanine green solution in imaging pelvic lymph nodes in patients with stage II prostate cancer undergoing surgery. Indocyanine green solution is a special dye that can help doctors see the lymph nodes and blood vessels during surgery when visualized under diffuse optical imaging. Indocyanine green solution may improve the ability to detect lymph nodes and may lead to improved accuracy of lymph node removal.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Stage 2, intermediate to high risk (per D'Amico criteria) localized prostate cancer with a prostate gland size =< 100 grams

• Intermediate risk: prostate specific antigen (PSA) between 10-20, Gleason grade 7, or clinical stage T2b

• High risk: PSA > 20 , Gleason grade >= 8, or clinical stage >= T2c

• Life expectancy of at least 10 years

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• The subject must be able to comply with the study procedures

• All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

• Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as total bilirubin > 1.5 x normal

• Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as serum glutamic oxaloacetic transaminase (SGOT) > 2 x normal

• Prior prostate surgery (i.e. transurethral resection of the prostate), or any prior abdominal or pelvic surgery, most specifically for surgeries that may have included any form of lymphadenectomy or anatomic changes

• History of androgen deprivation therapy, any prior chemotherapy, or any prior radiation therapy to the pelvis

• Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes

• Subject in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered

• Subject has any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure

• The presence of medical conditions contraindicating general anesthesia or standard surgical approaches