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Mesothelioma, MalignantNCT02519049

11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM)

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective exploratory study specifically investigating the role of 11C-Methionine PET/CT imaging in patients affected by Malignant Pleural Mesothelioma (MPM) and candidate to pleurodesis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mesothelioma, Malignant
How many people
30 participants
Where
1 siteItaly
Study dates
Sep 2014to Dec 2018
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: All patients affected by MPM and referred to our Institution for therapeutic pleurodesis and subsequent platinum- and pemetrexed-based chemotherapy will be enrolled. A minimum number of 20 patients will be considered for the analysis.

Who may be able to join

  • patients with an histological diagnosis of MPM eligible for pleurodesis and scheduled to undergo platinum- and pemetrexed-based chemotherapy.
  • obtained informed consent

Who cannot join

  • patients age <18 years
  • pregnancy or breast-feeding;
  • patients affected by other malignancies within the last 3 years;

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: Diagnostic and Prognostic Role of 11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM) and Candidate to Pleurodesis

Prospective exploratory study specifically investigating the role of 11C-Methionine PET/CT imaging in patients affected by Malignant Pleural Mesothelioma (MPM) and candidate to pleurodesis.

Read the detailed description

This is a single-center, open-label study, lasting 36 months including an estimated period of 24 months for the enrollment and max 12 months of follow-up. All patients affected by MPM and referred to our Institution eligible for therapeutic pleurodesis and subsequent platinum- and pemetrexed-based chemotherapy will be enrolled. In all cases patients will be investigated with 11C-Methionine PET/CT and 18F-FDG PET/CT before talc pleurodesis, one week after and at the end of three cycles of chemotherapy.

A minimum number of 20 patients will be considered for the analysis.

Being tested
No intervention
Keywords
Mesothelioma, 11C-methionine PET, talc pleurodesis
Medical subject headings
Mesothelioma, Malignant, Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    This is an observational study

What is being measured

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

  1. Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing talc pleurodesis

    Measured: Change from Baseline in SUVmax up to 1 week after talc pleurodesis.

Timeline

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

  1. First posted10 Aug 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionSep 2018
  4. Study completionDec 2018

Resources

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
Other
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02519049
Sponsor's protocol ID
1287
Status last verified
Sep 2020
First submitted
26 Jun 2015
Last updated
1 Oct 2020
Results posted
No
Data monitoring committee
No

Publications

  • Lopci E, Zucali PA, Ceresoli GL, Perrino M, Giordano L, Gianoncelli L, Lorenzi E, Gemelli M, Santoro A, Chiti A. Quantitative analyses at baseline and interim PET evaluation for response assessment and outcome definition in patients with malignant pleural mesothelioma. Eur J Nucl Med Mol Imaging. 2015 Apr;42(5):667-75. doi: 10.1007/s00259-014-2960-y. Epub 2014 Nov 18.

    PubMed 25403555

  • 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

  • Ceresoli GL, Chiti A, Santoro A. 11C-labeled methionine and evaluation of malignant pleural mesothelioma. N Engl J Med. 2007 Nov 8;357(19):1982-4. doi: 10.1056/NEJMc071823. No abstract available.

    PubMed 17989397

  • Lopci E, Novellis P, Testori A, Rahal D, Voulaz E, Bottoni E, Ferraroli GM, Crepaldi A, Ceresoli GL, Perrino M, Castello A, Alloisio M, Veronesi G, Zucali PA. In-vivo imaging of methionine metabolism in patients with suspected malignant pleural mesothelioma. Nucl Med Commun. 2019 Nov;40(11):1179-1186. doi: 10.1097/MNM.0000000000001078.

    PubMed 31568271

  • Zucali PA, Lopci E, Ceresoli GL, Giordano L, Perrino M, Ciocia G, Gianoncelli L, Lorenzi E, Simonelli M, De Vincenzo F, Setti LR, Bonifacio C, Bonomi M, Bombardieri E, Chiti A, Santoro A. Prognostic and predictive role of [18 F]fluorodeoxyglucose positron emission tomography (FDG-PET) in patients with unresectable malignant pleural mesothelioma (MPM) treated with up-front pemetrexed-based chemotherapy. Cancer Med. 2017 Oct;6(10):2287-2296. doi: 10.1002/cam4.1182. Epub 2017 Sep 21.

    PubMed 28941158

  • Bonomi M, De Filippis C, Lopci E, Gianoncelli L, Rizzardi G, Cerchiaro E, Bortolotti L, Zanello A, Ceresoli GL. Clinical staging of malignant pleural mesothelioma: current perspectives. Lung Cancer (Auckl). 2017 Aug 18;8:127-139. doi: 10.2147/LCTT.S102113. eCollection 2017.

    PubMed 28860886

  • Lopci E, Castello A, Testori A, Voulaz E, Rahal D, Perrino M, Crepaldi A, Ferraroli GM, Errico V, Bottoni E, Rodari M, Muraglia L, Marulli G, Alloisio M, Zucali PA. Malignant Pleural Mesothelioma (MPM) Evaluation with [11C]-Methionine PET/CT Before and After Talc Pleurodesis. Mol Imaging Biol. 2026 Apr;28(2):280-289. doi: 10.1007/s11307-026-02093-w. Epub 2026 Mar 9.

    PubMed 41801610

Questions about this trial

What is this clinical trial studying?

An observational study of Mesothelioma, Malignant, 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 1 Oct 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing talc pleurodesis (time frame: Change from Baseline in SUVmax up to 1 week after talc pleurodesis.). 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 NCT02519049, which also lists 7 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 1 Oct 2020.

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