Response Evaluation in Malignant Pleural Mesothelioma

Early Response Evaluation in Malignant Pleural Mesothelioma By Total Glycolytic Volume (TGV) Analysis of Serial FDG-PET Scans (Positron Emission Tomography Scans)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00969098

Enrollment

150

Registered

2009-08-31

Start date

2009-06-30

Completion date

2015-09-30

Last updated

2015-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Pleural Mesothelioma

Keywords

Histologically proven of Malignant pleural mesothelioma;, Patients not candidate to radical surgery;, Candidate to first-line pemetrexed-based chemotherapy;

Brief summary

Recently, a few small trials have shown promising results on value of fluoro-2-deoxy-D-glucose and positron emission tomography imaging in response assessment in Malignant Pleural Mesothelioma. These studies considered different parameters in Positron Emission Tomography (PET) analysis, mainly the standardized uptake value and volume-based parameters such as total glycolytic volume.

Detailed description

This is a retrospective analysis of two consecutive and homogeneous series of Malignant Pleural Mesothelioma patients treated with first-line pemetrexed-based chemotherapy and evaluated by CT scan and FDG-PET.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically proven MALIGNANT PLEURAL MESOTHELIOMA * Patients not candidate to radical surgery * Unidimensionally and/or bidimensionally CT-measurable disease and Candidate to first-line pemetrexed-based chemotherapy

Exclusion criteria

* Histologically not proven MALIGNANT PLEURAL MESOTHELIOMA

Design outcomes

Primary

Measure	Time frame
To validate a semi-automated iterative threshold-based region growing algorithm in a previously published series of patients.	4 months

Secondary

Measure	Time frame
To extend the analysis to another series of consecutive patients with MALIGNANT PLEURAL MESOTHELIOMA treated with first-line pemetrexed-based chemotherapy, and to perform a combined analysis of the two groups.	4 months
To validate the new liver-based threshold semi-automated algorithm on the GE ADW4.6 workstation with the algorithm validated in step 1 in the same subset of patients.	4 months

Countries

Italy

Outcome results