Volumetric Imaging Follow up of Patients With Liver Metastases of Small Intestinal Neuroendocrine Tumors (NETs). (VOLUNET)

September 26, 2018 updated by: Hospices Civils de Lyon

More than 50% of intestinal NETs are metastatic at the time of diagnosis, the liver being the main affected organ in 50-90% of cases.

Initial liver tumor burden and slope of the tumor growth rate are two major prognostic factors in patients with intestinal NETs, followed by tumor grade at pathology. They are used in routine practice by oncologists to adapt patient treatment.

Unlike other tumors, most NETs metastases are slow-growing tumors. Previous studies have shown that approximately half of the patients diagnosed with liver metastases showed no progression over a period of 3 to 6 months.

The aim of this non randomised retrospective cohort study is to investigate whether the volumetric monitoring of the total tumor burden compared to the RECIST 1.1 criteria (used in routine practice by radiologists) at baseline and early follow-up (3 to 6 months) is more suitable for NETs, making possible to predict the prognosis at the onset of the disease, and also allowing a better adaptation of the treatment.

The secondary objectives are to evaluate if the initial volume of the liver tumor is a prognostic factor of time to progression, to correlate the initial liver tumor volume and the number of liver lesions to the blood concentration of Chromogranin A (CgA), the presence of extra-abdominal disease and to correlate the tumor growth rate (TGR) and KI 67 (%) at base-line.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Service de radiologie-Pavillon B-Cellule Recherche imagerie - Hôpital Edouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients over 18 years old, with intestinal well differentiated intestinal neuroendocrine tumor and with at least one liver metastasis, without any invasive or systemic treatment for liver metastasis (Somatostatin analogues only allowed).

Description

Inclusion Criteria:

  • Well differentiated intestinal neuroendocrine tumor with at least one liver metastasis
  • The liver metastasis must be visible and measurable on CT scans or MRI
  • Patients monitored without invasive liver treatment : surgery, RF ablation / Trans-arterial chemoembolization
  • Patients monitored without systemic treatment such as: Chemotherapy, Everolimus, Sunitinib (Somatostatin analogues allowed)
  • Surgery of the primary tumor allowed

Exclusion Criteria:

  • Other type of NETs
  • Absence of liver metastases
  • Liver metastases not visible on CT scans/MRI, poorly limited lesions and small target lesions ( less than 10mm) that are difficult to measure
  • Lesions visible only on diffusion-weighted imaging -MRI acquisitions, thus presenting poorly limited contours
  • Invasive liver treatment : surgery, Radio frequency / Trans-arterial chemoembolization
  • Systemic treatments: Chemotherapy / Everolimus / Sunitinib
  • Insufficient follow-up data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Could the evolution of the initial liver tumor volume (on two follow-up CT scans / MRI over a period of 3 to 6 months) be predictive of progression-free survival according to the RECIST criteria?
Time Frame: 6 months
To assess if the evolution of the initial liver tumor volume compared to a follow-up CT scans / MRI over a period of 3 to 6 months is predictive of progression-free survival according to the RECIST criteria
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Could the evolution of the initial liver tumor volume (on two follow-up CT scans / MRI over a period of 3 to 6 months) be predictive of progression-free survival according to the RECIST criteria?
Time Frame: 6 months
To evaluate whether the initial volume of the liver tumor is a prognostic factor of time to progression
6 months
Could the evolution of the initial liver tumor volume (on two follow-up CT scans / MRI over a period of 3 to 6 months) be predictive of progression-free survival according to the RECIST criteria?
Time Frame: 6 months
To determine the tumor growth rate
6 months
Could the evolution of the initial liver tumor volume (on two follow-up CT scans / MRI over a period of 3 to 6 months) be predictive of progression-free survival according to the RECIST criteria?
Time Frame: 6 months
To estimate the evolution of tumor volume as a function of time that may anticipate earlier than RECIST the tumor growth
6 months
Could the evolution of the initial liver tumor volume (on two follow-up CT scans / MRI over a period of 3 to 6 months) be predictive of progression-free survival according to the RECIST criteria?
Time Frame: 6 months
To correlate the initial liver tumor volume and the number of liver lesions to the blood concentration of Chromogranin A (CgA) and the presence of extra-abdominal disease.
6 months
Could the evolution of the initial liver tumor volume (on two follow-up CT scans / MRI over a period of 3 to 6 months) be predictive of progression-free survival according to the RECIST criteria?
Time Frame: 6 months
To correlate the tumor growth rate (TGR) and KI 67 (%) at base-line (on liver metastasis if available or on primary tumor)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

August 30, 2018

Study Completion (Anticipated)

December 30, 2018

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VOLUNET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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