Image-guided Lymphadanectomy in AMIGO

To perform image-guided laparoscopic intra-abdominal lymph node biopsy with goal of minimizing surgical risk and improving accuracy of biopsy.

Study Overview

• Status: Unknown
• Conditions: Lymphoma; Lymphadenopathy Retroperitoneal
• Intervention / Treatment: Device: Image-guided Lymphadanectomy in AMIGO

Detailed Description

Only the superficial lymph nodes are accessible to physical examination, and assessment of deeper nodes, such as those in the abdomen, requires radiological imaging. As a result, abdominal CT and PET scanning of patients with a history of malignancy or concerns for a new diagnosis of cancer is an important diagnostic test. As well as looking for distant metastasis, the images are carefully assessed for evidence of intra-abdominal lymphadenopathy, which can be a marker of new or recurrent cancer. If such nodes are identified, they often require a biopsy for further evaluation.

The lymph nodes located in the abdomen or the retroperitoneum are not easily accessible for percutaneous biopsy, often requiring an abdominal exploration which can be done either laparoscopically or via laparotomy. The laparoscopic approach represents a better approach that is associated with reduced surgical risks and complications as well as a quicker recover. In fact in many cases, the laparoscopic approach can be done as a day surgery procedure.

Although non-invasive imaging technologies such as computed tomography (CT) scanning, magnetic resonance imaging (MRI), and positron emission tomography (PET) scanning can be useful in the diagnosis of lymphadenopathy, they often provide an estimate of the location of the nodes, and exact localization of the lymph node of interest can be challenging. The surgeons rely on anatomical landmarks which can be distorted during laparoscopy and to help reduce the rate of false negative lymph node biopsy, the surgeons often perform intra-operative histological assessment of the lymph nodes (Frozen Section) which can be time consuming and in itself associated with diagnostic errors. The uncertainty about the exact location of the node of interest often leads to extensive surgical dissection, biopsy of multiple nodes, and sometimes repeat surgery. During the dissection, care must be taken to avoid injury to the neighboring structures, such as blood vessels, nerves or adjacent organs. In cases, where an intra-operative dissection occurs, or lymph nodes can not be identified, the laparoscopic surgery is converted to open surgery.

Using the unique capabilities of the AMIGO suite, investigators aim to test intra-operative image guidance to help them identify diseased intra-abdominal lymph nodes, allowing for more precise and safer surgeries. The improved accuracy will allow investigators to perform surgeries with minimal dissection and reduced complications while improving biopsy rates and enhancing ability to accurately stage intra-abdominal malignancies.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ali Tavakkoli, MD; Phone Number: 6177326337; Email: atavakkoli@bwh.harvard.edu
• Study Contact Backup: Name: Jayender Jagadeesen, PhD; Phone Number: 617-278-0986; Email: jayender@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed written informed consent before any trial related procedure is undertaken that is not part of the standard patient management
• Subjects aged ≥ 18 years. Selected patients must have a confirmed or suspected diagnosis of disease in the abdomen or retroperitoneum, with scheduled confirmatory surgical biopsy.
• Subjects must have had a CT, PET examination or MR examination of acceptable quality at Brigham and Women's Hospital within the prior month

Exclusion Criteria:

• Severely impaired renal function with an EGFR < 30 mL/min/body surface area
• Evidence of any significant, uncontrolled comorbid condition that could affect compliance with the protocol or interpretation of the results, which is to be judged at the discretion of the PI
• History of hypersensitivity or other contraindication to contrast media
• Contraindication to general anesthesia
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Accuracy of lymph node biopsy	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: KARL STORZ Endoscopy-America, Inc.; Siemens Corporation, Corporate Technology
• Investigators: Principal Investigator: Ali Tavakkoli, MD, Brigham and Women's Hopistal

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2017
• Primary Completion (ANTICIPATED): January 1, 2019
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (ACTUAL): September 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphadenopathy
• Other Study ID Numbers: 2016P002535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes