Image-guided Lymphadanectomy in AMIGO

Lymphoma Clinical Trial

Official title:

Image-guided Lymphadanectomy in AMIGO

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03283423
• Other study ID #: 2016P002535
• Status: Not yet recruiting
• Phase: N/A
• First received: September 11, 2017
• Last updated: September 12, 2017
• Start date: November 2017
• Est. completion date: March 2019

Study information

• Verified date: September 2017
• Source: Brigham and Women's Hospital
• Contact: Ali Tavakkoli, MD
• Phone: 6177326337
• Email: atavakkoli[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphadenopathy Retroperitoneal
• Lymphatic Diseases
• Lymphoma

Intervention

Device:
• Image-guided Lymphadanectomy in AMIGO
Image guided laparoscopic lymph node biopsy

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	KARL STORZ Endoscopy-America, Inc., Siemens Corporation, Corporate Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of lymph node biopsy		through study completion, an average of 1 year