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Trial record 22 of 1313 for:    survival | Neuroendocrine Tumors

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

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ClinicalTrials.gov Identifier: NCT03689231
Recruitment Status : Active, not recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date September 26, 2018
First Posted Date September 28, 2018
Last Update Posted Date September 28, 2018
Actual Study Start Date March 1, 2018
Actual Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2018)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 26, 2018)
  • 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
  • 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
  • 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
  • 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.
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Volumetric Imaging Follow up of Patients With Liver Metastases of Small Intestinal Neuroendocrine Tumors (NETs).
Official Title Volumetric Imaging Follow up of Patients With Liver Metastases of Small Intestinal Neuroendocrine Tumors (NETs).
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • Neuroendocrine Tumors
  • Liver Metastases
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.

Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 26, 2018)
80
Original Actual Enrollment Same as current
Estimated Study Completion Date December 30, 2018
Actual Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03689231
Other Study ID Numbers VOLUNET
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date September 2018