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Lymphadenopathy RetroperitonealNCT03283423

Image-guided Lymphadanectomy in AMIGO

A study testing Image-guided Lymphadanectomy in AMIGO in people with Lymphadenopathy Retroperitoneal and Lymphoma, run by Brigham and Women's Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphadenopathy Retroperitoneal, Lymphoma
What is being tested?
Image-guided Lymphadanectomy in AMIGO
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
25 Oct 2018to 20 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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

Read the 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.

Being tested
Image-guided Lymphadanectomy in AMIGO
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Image-guided Lymphadanectomy in AMIGODevice

    Image guided laparoscopic lymph node biopsy

Study groups in NCT03283423
Study groupRoleWhat they receive
Image Guided ArmExperimentalWill receive Image guided lymph node biopsy
Receives: Device: Image-guided Lymphadanectomy in AMIGO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of lymph node biopsy

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2017
  2. Study start25 Oct 2018
  3. Primary completion20 Mar 2020
  4. Study completion20 Mar 2020

Why it stopped: Due to COVID and OR access

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03283423
Sponsor's protocol ID
2016P002535
Status last verified
Jan 2026
First submitted
11 Sep 2017
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Image-guided Lymphadanectomy in AMIGO in people with Lymphadenopathy Retroperitoneal and Lymphoma, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to COVID and OR access). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of lymph node biopsy (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.

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