Malignant Pleural MesotheliomaNCT00969098

Response Evaluation in Malignant Pleural Mesothelioma

An observational study of Malignant Pleural Mesothelioma, run by Istituto Clinico Humanitas at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Malignant Pleural Mesothelioma
How many people: 150 participants
Where: 1 siteItaly
Study dates: Jun 2009to Sep 2015
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Histologically proven MALIGNANT PLEURAL MESOTHELIOMA and Patients not candidate to radical surgery

Who may be able to join

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

Who cannot join

Histologically not proven MALIGNANT PLEURAL MESOTHELIOMA

Trial locations and contacts

1 site in 1 country.

Italy1 site

Istituto Clinico Humanitas
Rozzano, Milano, 20089

Other trials in Italy

About this study

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

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.

Read the 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.

Conditions: Malignant Pleural Mesothelioma
Keywords: Histologically proven of Malignant pleural mesothelioma;, Patients not candidate to radical surgery;, Candidate to first-line pemetrexed-based chemotherapy;
Medical subject headings: Mesothelioma, Malignant

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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.
Measured: 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.
Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Sep 2015

First posted31 Aug 2009 (estimated)
Study startJun 2009
Primary completionAug 2015
Study completionSep 2015 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00969098
Sponsor's protocol ID: ONC/OSS-02/2009
Status last verified: Aug 2015
First submitted: 6 Aug 2009
Last updated: 6 Aug 2015
Results posted: No
Data monitoring committee: No

Publications

Robinson BW, Musk AW, Lake RA. Malignant mesothelioma. Lancet. 2005 Jul 30-Aug 5;366(9483):397-408. doi: 10.1016/S0140-6736(05)67025-0.
PubMed 16054941
Sugarbaker DJ, Flores RM, Jaklitsch MT, Richards WG, Strauss GM, Corson JM, DeCamp MM Jr, Swanson SJ, Bueno R, Lukanich JM, Baldini EH, Mentzer SJ. Resection margins, extrapleural nodal status, and cell type determine postoperative long-term survival in trimodality therapy of malignant pleural mesothelioma: results in 183 patients. J Thorac Cardiovasc Surg. 1999 Jan;117(1):54-63; discussion 63-5. doi: 10.1016/s0022-5223(99)70469-1.
PubMed 9869758
Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. doi: 10.1200/JCO.2003.11.136.
PubMed 12860938
Ceresoli GL, Zucali PA, Favaretto AG, Grossi F, Bidoli P, Del Conte G, Ceribelli A, Bearz A, Morenghi E, Cavina R, Marangolo M, Parra HJ, Santoro A. Phase II study of pemetrexed plus carboplatin in malignant pleural mesothelioma. J Clin Oncol. 2006 Mar 20;24(9):1443-8. doi: 10.1200/JCO.2005.04.3190.
PubMed 16549838
Ceresoli GL, Chiti A, Zucali PA, Cappuzzo F, De Vincenzo F, Cavina R, Rodari M, Poretti D, Lutman FR, Santoro A. Assessment of tumor response in malignant pleural mesothelioma. Cancer Treat Rev. 2007 Oct;33(6):533-41. doi: 10.1016/j.ctrv.2007.07.012. Epub 2007 Aug 30.
PubMed 17764849
Byrne MJ, Nowak AK. Modified RECIST criteria for assessment of response in malignant pleural mesothelioma. Ann Oncol. 2004 Feb;15(2):257-60. doi: 10.1093/annonc/mdh059.
PubMed 14760119
Flores RM, Akhurst T, Gonen M, Zakowski M, Dycoco J, Larson SM, Rusch VW. Positron emission tomography predicts survival in malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2006 Oct;132(4):763-8. doi: 10.1016/j.jtcvs.2006.03.068.
PubMed 17000285
Flores RM, Akhurst T, Gonen M, Larson SM, Rusch VW. Positron emission tomography defines metastatic disease but not locoregional disease in patients with malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2003 Jul;126(1):11-6. doi: 10.1016/s0022-5223(03)00207-1.
PubMed 12878934
Weber WA. Use of PET for monitoring cancer therapy and for predicting outcome. J Nucl Med. 2005 Jun;46(6):983-95.
PubMed 15937310
Ceresoli GL, Chiti A, Zucali PA, Rodari M, Lutman RF, Salamina S, Incarbone M, Alloisio M, Santoro A. Early response evaluation in malignant pleural mesothelioma by positron emission tomography with [18F]fluorodeoxyglucose. J Clin Oncol. 2006 Oct 1;24(28):4587-93. doi: 10.1200/JCO.2006.06.8999.
PubMed 17008700

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
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Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
Active, not recruitingPhase 3
MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
Unresectable Pleural Mesothelioma
Active, not recruitingPhase 1/2
Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma
Epithelioid Mesothelioma, Pleural Malignant Mesothelioma
Active, not recruitingPhase 1
Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma
Biphasic Mesothelioma, Epithelioid Mesothelioma

All Malignant Pleural Mesothelioma trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Response Evaluation in Malignant Pleural Mesothelioma By Total Glycolytic Volume (TGV) Analysis of Serial FDG-PET Scans (Positron Emission Tomography Scans)
ClinicalTrials.gov ID: NCT00969098
Acronym / sponsor ID: ONC/OSS-02/2009
Conditions: Malignant Pleural Mesothelioma
Keywords: Histologically proven of Malignant pleural mesothelioma;, Patients not candidate to radical surgery;, Candidate to first-line pemetrexed-based chemotherapy;
Study type: Observational
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: Istituto Clinico HumanitasUniversity, hospital or other
Study start: Jun 2009
Primary completion: Aug 2015 (actual)
Study completion: Sep 2015 (estimated)
First posted: 31 Aug 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Histologically proven MALIGNANT PLEURAL MESOTHELIOMA and Patients not candidate to radical surgery

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Histologically not proven MALIGNANT PLEURAL MESOTHELIOMA

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

2 secondary outcomes

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.
Time frame: 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.
Time frame: 4 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
Background: PubMed 16054941Robinson BW, Musk AW, Lake RA. Malignant mesothelioma. Lancet. 2005 Jul 30-Aug 5;366(9483):397-408. doi: 10.1016/S0140-6736(05)67025-0.
Background: PubMed 9869758Sugarbaker DJ, Flores RM, Jaklitsch MT, Richards WG, Strauss GM, Corson JM, DeCamp MM Jr, Swanson SJ, Bueno R, Lukanich JM, Baldini EH, Mentzer SJ. Resection margins, extrapleural nodal status, and cell type determine postoperative long-term survival in trimodality therapy of malignant pleural mesothelioma: results in 183 patients. J Thorac Cardiovasc Surg. 1999 Jan;117(1):54-63; discussion 63-5. doi: 10.1016/s0022-5223(99)70469-1.
Background: PubMed 12860938Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. doi: 10.1200/JCO.2003.11.136.
Background: PubMed 16549838Ceresoli GL, Zucali PA, Favaretto AG, Grossi F, Bidoli P, Del Conte G, Ceribelli A, Bearz A, Morenghi E, Cavina R, Marangolo M, Parra HJ, Santoro A. Phase II study of pemetrexed plus carboplatin in malignant pleural mesothelioma. J Clin Oncol. 2006 Mar 20;24(9):1443-8. doi: 10.1200/JCO.2005.04.3190.
Background: PubMed 17764849Ceresoli GL, Chiti A, Zucali PA, Cappuzzo F, De Vincenzo F, Cavina R, Rodari M, Poretti D, Lutman FR, Santoro A. Assessment of tumor response in malignant pleural mesothelioma. Cancer Treat Rev. 2007 Oct;33(6):533-41. doi: 10.1016/j.ctrv.2007.07.012. Epub 2007 Aug 30.
Background: PubMed 14760119Byrne MJ, Nowak AK. Modified RECIST criteria for assessment of response in malignant pleural mesothelioma. Ann Oncol. 2004 Feb;15(2):257-60. doi: 10.1093/annonc/mdh059.
Background: PubMed 17000285Flores RM, Akhurst T, Gonen M, Zakowski M, Dycoco J, Larson SM, Rusch VW. Positron emission tomography predicts survival in malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2006 Oct;132(4):763-8. doi: 10.1016/j.jtcvs.2006.03.068.
Background: PubMed 12878934Flores RM, Akhurst T, Gonen M, Larson SM, Rusch VW. Positron emission tomography defines metastatic disease but not locoregional disease in patients with malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2003 Jul;126(1):11-6. doi: 10.1016/s0022-5223(03)00207-1.
Background: PubMed 15937310Weber WA. Use of PET for monitoring cancer therapy and for predicting outcome. J Nucl Med. 2005 Jun;46(6):983-95.
Background: PubMed 17008700Ceresoli GL, Chiti A, Zucali PA, Rodari M, Lutman RF, Salamina S, Incarbone M, Alloisio M, Santoro A. Early response evaluation in malignant pleural mesothelioma by positron emission tomography with [18F]fluorodeoxyglucose. J Clin Oncol. 2006 Oct 1;24(28):4587-93. doi: 10.1200/JCO.2006.06.8999.

Related trials for Malignant Pleural Mesothelioma

RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
Active, not recruitingPhase 3
MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
Unresectable Pleural Mesothelioma
Active, not recruitingPhase 1/2
Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma
Epithelioid Mesothelioma, Pleural Malignant Mesothelioma
Active, not recruitingPhase 1
Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma
Biphasic Mesothelioma, Epithelioid Mesothelioma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Armando Santoro, MD principal investigator

Istituto Clinico Humanitas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Malignant Pleural Mesothelioma, run by Istituto Clinico Humanitas at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To validate a semi-automated iterative threshold-based region growing algorithm in a previously published series of patients. (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00969098, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.