An observational study in Neuroendocrine Tumors and Liver Metastases, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-28.
Sponsored by Hospices Civils de Lyon · Observational
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 80 is below the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.
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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).
Exclusion Criteria:
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.
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
Time frame: 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?
To evaluate whether the initial volume of the liver tumor is a prognostic factor of time to progression
Time frame: 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?
To determine the tumor growth rate
Time frame: 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?
To estimate the evolution of tumor volume as a function of time that may anticipate earlier than RECIST the tumor growth
Time frame: 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?
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.
Time frame: 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?
To correlate the tumor growth rate (TGR) and KI 67 (%) at base-line (on liver metastasis if available or on primary tumor)
Time frame: 6 months
Plan to share: No
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Hospices Civils de Lyon