A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping



Status:Completed
Conditions:Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Women's Studies, Endometrial Cancer
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:December 2015
End Date:June 2017

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A Randomized, Prospective, Open Label, Multicenter Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping

This is a randomized, prospective, open label, multicenter study to assess the safety and
utility of PINPOINT® Near Infrared Fluorescence Imaging (PINPOINT) in identification of lymph
nodes (LN) in patients with uterine and cervical malignancies who are undergoing LN mapping.


Inclusion Criteria:

- 18 years of age or older

- Subjects with FIGO Clinical Stage I endometrial cancer undergoing minimally invasive
hysterectomy with lymph node mapping.

- Subjects with FIGO Clinical Stage IA cervical cancer ≤ 2 cm in size undergoing
minimally invasive hysterectomy, trachelectomy, or conization with lymph node mapping.
Subjects with clinical Stage IA1 cervical cancer without lympho vascular space
involvement (LVSI) and negative margins on cone biopsy are not to be included.

- Subjects with negative nodal status (N0)

- Subjects with negative metastatic involvement (M0).

Exclusion Criteria:

- Have had prior dissection and/or radiation in pelvis.

- Advanced cervical or endometrial cancer, T3/T4 lesions

- Diagnosis of cervical cancer with a tumor size greater than 2 cm.

- Locally advanced or inflammatory cervical or uterine cancer

- Metastatic cervical or uterine cancer.

- Known allergy or history of adverse reaction to ICG, iodine or iodine dyes.

- Known allergy or history of adverse reaction to Blue dye (Isosulfan blue) or
triphenylmethane.

- Hepatic dysfunction defined as MELD Score > 12.

- Renal dysfunction defined as serum creatinine ≥ 2.0 mg/dl.

- Subjects who have participated in another investigational study within 30 days prior
to surgery.

- Pregnant or lactating subjects.

- Subjects who, in the Investigator's opinion, have any medical condition that makes the
subject a poor candidate for the investigational procedure, or interferes with the
interpretation of study results.
We found this trial at
6
sites
Fort Myers, Florida 33901
Principal Investigator: Samith Sandadi, MD
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20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Principal Investigator: Fidel Valea, MD
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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Houston, Texas 77030
Principal Investigator: Michael Frumovitz
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New York, New York 10065
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New York, NY
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San Jose, California 95128
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San Jose, CA
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2075 Bayview Avenue
Toronto, Ontario M4N 3M5
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Toronto,
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