NCT03283423

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 25, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

September 11, 2017

Last Update Submit

January 8, 2026

Conditions

LymphomaLymphadenopathy Retroperitoneal

Outcome Measures

Primary Outcomes (1)

  • Accuracy of lymph node biopsy

    through study completion, an average of 1 year

Study Arms (1)

Image Guided Arm

EXPERIMENTAL

Will receive Image guided lymph node biopsy

Device: Image-guided Lymphadanectomy in AMIGO

Interventions

Image-guided Lymphadanectomy in AMIGODEVICE

Image guided laparoscopic lymph node biopsy

Image Guided Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Ali Tavakkoli, MD

    Brigham and Women's Hopistal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Surgeon

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 14, 2017

Study Start

October 25, 2018

Primary Completion

March 20, 2020

Study Completion

March 20, 2020

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)