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

Neuroendocrine Tumors Clinical Trial

— VOLUNET  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03689231
• Other study ID #: VOLUNET
• Status: Active, not recruiting
• Start date: March 1, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: September 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Neuroendocrine Tumors

Intervention

Other:
• Volumetric measurements of liver metastases
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.

Locations

Country	Name	City	State
France	Service de radiologie-Pavillon B-Cellule Recherche imagerie - Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 evaluate whether the initial volume of the liver tumor is a prognostic factor of time to progression	6 months
Secondary	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 determine the tumor growth rate	6 months
Secondary	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 estimate the evolution of tumor volume as a function of time that may anticipate earlier than RECIST the tumor growth	6 months
Secondary	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 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
Secondary	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 correlate the tumor growth rate (TGR) and KI 67 (%) at base-line (on liver metastasis if available or on primary tumor)	6 months