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

NCT03689231 | Unknown

• 1 other identifier: VOLUNET
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuroendocrine Tumors; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• 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?

  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 Outcomes (5)

• 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?

  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?

  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?

  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?

  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?

  6 months

Interventions

Volumetric measurements of liver metastases OTHER

Depending on the available data and to be reproducible, patients will be divided into 2 sub-groups of follow-up imaging: CT only or MRI only, combined evaluation being not reliable for tumor detection Patient follow-up at CT or MRI will be analyzed at baseline (date of discovery of hepatic metastatic disease), then 3-6 months after the start of the study, then annually. At each assessment, a radiologist will analyze: the total volume of liver metastases (mm3), the estimated volume of the two target lesions chosen for RECIST follow-up (mm3), the number of liver lesions, and the evolution according to the RECIST criteria based on uni-dimensional measurements. We will then correlate the following clinical data collected for patients: age, sex, presence of a carcinoid syndrome, Ki67 (%) and chromogranin A blood level (%) at diagnosis, number and location of other metastases, Octreoscan or Stereotactic Radio Surgery data if available.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de radiologie-Pavillon B-Cellule Recherche imagerie - Hôpital Edouard Herriot

Lyon, 69003, France

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: March 1, 2018
• Primary Completion: August 30, 2018
• Study Completion: December 30, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)